Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008812251

FEI Number

3002808293

Entity Name

Swann-Morton(Services) Limited

City/State/Country

Owlerton Green Sheffield, GB

Establishment Address

Penn Works, Owlerton Green Sheffield S6 2BJ, GB

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

SWANN MORTON, LTD. (Owner Number: 9003320)

Owner / Operator Contact Address

OWLERTON GREEN, --, SHEFFIELD, GB-NOTA --, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Acess Abutments Neoss Access Abutments 110060000 GLOBAL UNITE 122032062 DURALOC 122032466 DURALOC 122032454 DURALOC 122032066 DURALOC 122032156 DURALOC 122032452 DURALOC 122032154 DURALOC 122032060 DURALOC 122032464 DURALOC 122032162 DURALOC 122028450 DURALOC 122032152 DURALOC 122032164 DURALOC 122032056 DURALOC 122032058 DURALOC 122032458 DURALOC 122032064 DURALOC 122032166 DURALOC 122032462 DURALOC 122032456 DURALOC 122032054 DURALOC 122032460 DURALOC 122032052 DURALOC 122028448 DURALOC 122032158 DURALOC 122032160 DURALOC Wick and Wipe Cellulose Point Lasik Drain Instrument Wipe PVA Point PVA Spear Lasik Shield Eye Drain Eye Shield Eye Wick Cellulose Spear 136511000 Modular Femoral Heads 136511500 Pinnacle Hip System 136513500 Pinnacle Hip System 136513000 Modular Femoral Heads 136512000 Modular Femoral Heads 136512500 Pinnacle Hip System 136523000 Modular Femoral Heads 136524000 Modular Femoral Heads 136521000 Modular Femoral Heads 136525000 Modular Femoral Heads 136522000 Modular Femoral Heads Cervical Biopsy Punch 110040000 GLOBAL UNITE 110030010 GLOBAL UNITE 110050020 GLOBAL UNITE 110040010 GLOBAL UNITE 110020000 GLOBAL UNITE 110050000 GLOBAL UNITE 110050010 GLOBAL UNITE 110060010 GLOBAL UNITE 110030020 GLOBAL UNITE 110020010 GLOBAL UNITE 110020020 GLOBAL UNITE 110060020 GLOBAL UNITE 110030000 GLOBAL UNITE 110040020 GLOBAL UNITE 136544500 Pinnacle Hip System 136564500 Pinnacle Hip System 136565500 Pinnacle Hip System 136579500 Pinnacle Hip System 136569500 Pinnacle Hip System 136567000 Pinnacle Hip System 11/13 40mm MSpec Head 12/14 40MM Mspec Head 136541500 Pinnacle Hip System 136561000 Pinnacle Hip System 136504000 Pinnacle Hip System 136566500 Pinnacle Hip System 136507000 Pinnacle Hip System 136564000 Pinnacle Hip System 136542500 Pinnacle Hip System 136568000 Pinnacle Hip System 136545500 Pinnacle Hip System 136569000 Pinnacle Hip System 136570000 Pinnacle Hip System 136508000 Pinnacle Hip System 136570500 Pinnacle Hip System 136579000 Pinnacle Hip System 136561500 Pinnacle Hip System 136580000 Pinnacle Hip System 136563500 Pinnacle Hip System 136505000 Pinnacle Hip System 136547500 Pinnacle Hip System 136562000 Pinnacle Hip System 136506000 Pinnacle Hip System 12/14 44mm MSpec Head 136565000 Pinnacle Hip System 136543500 Pinnacle Hip System 136580500 Pinnacle Hip System 136509000 Pinnacle Hip System 136563000 Pinnacle Hip System 136581500 Pinnacle Hip System 136560000 Pinnacle Hip System 136562500 Pinnacle Hip System EZ Strip EZ-Squeeze 124580053 Duraloc Hip System 124580052 Duraloc Hip System 124580051 Duraloc Hip System 124580058 Duraloc Hip System 124580056 Duraloc Hip System 124580057 Duraloc Hip System 124580054 Duraloc Hip System 124946000 Acetabular Revision Components 124580055 Duraloc Hip System 124580049 Duraloc Hip System 124580050 Duraloc Hip System 962569000 Elite Plus Hip System 962570000 Elite Plus Hip System Strip Schirmer SCHIRMER TEAR TEST Membrane Screws and Membrane Tacks SCREW, FIXATION, INTAOSSEOUS 122070128 S-ROM MARATHON 122072132 S-ROM MARATHON 122072332 S-ROM MARATHON 122070328 S-ROM MARATHON 136552000 Pinnacle Hip System 136530000 Pinnacle Hip System 136529000 Pinnacle Hip System 136503000 Hip Product 136554000 Pinnacle Hip System 136502000 Hip Product 136553000 Pinnacle Hip System 136551000 Pinnacle Hip System 136550000 Pinnacle Hip System Oral Rotating Biopsy Punch Medial Rotation Knee system Neoss Implant System 3.25 Dental Implant System OS309105 6.5MM X 105MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309050 6.5MM X 50MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309085 6.5MM X 85MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309065 6.5MM X 65MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309100 6.5MM X 100MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS201526 REAMING ROD 2.6MM X 900MM OLIVE OS309115 6.5MM X 115MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309030 6.5MM X 30MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309040 6.5MM X 40MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309035 6.5MM X 35MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309060 6.5MM X 60MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309080 6.5MM X 80MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309055 6.5MM X 55MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309120 6.5MM X 120MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309045 6.5MM X 45MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309095 6.5MM X 95MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309075 6.5MM X 75MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS333523 MISS GRADUATED K-WIRE OS309070 6.5MM X 70MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309110 6.5MM X 110MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD OS309090 6.5MM X 90MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD 330793062 PINNACLE 330793064 PINNACLE 330791048 PINNACLE 330791064 PINNACLE 330793060 PINNACLE 330791058 PINNACLE 330791056 PINNACLE 330790056 PINNACLE 330793048 PINNACLE 330791066 PINNACLE 330792064 PINNACLE 330793058 PINNACLE 330792062 PINNACLE 330792052 PINNACLE 330792048 PINNACLE 330793054 PINNACLE 330790060 PINNACLE 330790064 PINNACLE 330791054 PINNACLE 330791062 PINNACLE 330793056 PINNACLE 330791050 PINNACLE 330793050 PINNACLE 330792054 PINNACLE 330792050 PINNACLE 330793066 PINNACLE 330792060 PINNACLE 330792058 PINNACLE 330792066 PINNACLE 330792056 PINNACLE 330790062 PINNACLE 330793052 PINNACLE 330790052 PINNACLE 330790054 PINNACLE 330791060 PINNACLE 330790050 PINNACLE 330790066 PINNACLE 330791052 PINNACLE 330790048 PINNACLE 330790058 PINNACLE OS330100 OXBRIDGE AFN 5MM X 100MM CORTICAL SCREW (Ti6Al4V) OS330040 OXBRIDGE AFN 5MM X 40MM CORTICAL SCREW (Ti6Al4V) OS330095 OXBRIDGE AFN 5MM X 95MM CORTICAL SCREW (Ti6Al4V) OS331150N OXBRIDGE ANKLE FUSION NAIL 10MM X 150MM (Ti6Al4V) OS332150N OXBRIDGE ANKLE FUSION NAIL 12MM X 150MM (Ti6Al4V) OS330075 OXBRIDGE AFN 5MM X 75MM CORTICAL SCREW (Ti6Al4V) OS331106 OXBRIDGE AFN END CAP DIA 12MM X 10MM LONG OS331118N OXBRIDGE ANKLE FUSION NAIL 11MM X 180MM (Ti6Al4V) OS333003 OXBRIDGE AFN 4MM DRILL - SHORT OS330032 OXBRIDGE AFN 5MM X 32MM CORTICAL SCREW (Ti6Al4V) OS330110 OXBRIDGE AFN 5MM X 110MM CORTICAL SCREW (Ti6Al4V) OS330080 OXBRIDGE AFN 5MM X 80MM CORTICAL SCREW (Ti6Al4V) OS330105 OXBRIDGE AFN 5MM X 105MM CORTICAL SCREW (Ti6Al4V) OS331101 OXBRIDGE AFN END CAP DIA 10MM X 5MM LONG OS331180N OXBRIDGE ANKLE FUSION NAIL 10MM X 180MM (Ti6Al4V) OS330085 OXBRIDGE AFN 5MM X 85MM CORTICAL SCREW (Ti6Al4V) OS331102 OXBRIDGE AFN END CAP DIA 10MM X 10MM LONG OS333015 8MM CANNULATED STARTER REAMER OS330036 OXBRIDGE AFN 5MM X 36MM CORTICAL SCREW (Ti6Al4V) OS333019 OXBRIDGE ANKLE FUSION NAIL EXCHANGE TUBE 6MM OS333525 AFN MISS 5MM CANNULATED DRILL OS330050 OXBRIDGE AFN 5MM X 50MM CORTICAL SCREW (Ti6Al4V) OS330028 OXBRIDGE AFN 5MM X 28MM CORTICAL SCREW (Ti6Al4V) OS330115 OXBRIDGE AFN 5MM X 115MM CORTICAL SCREW (Ti6Al4V) OS330090 OXBRIDGE AFN 5MM X 90MM CORTICAL SCREW (Ti6Al4V) OS331115N OXBRIDGE ANKLE FUSION NAIL 11MM X 150MM (Ti6Al4V) OS330022 OXBRIDGE AFN 5MM X 22MM CORTICAL SCREW (Ti6Al4V) OS331100 OXBRIDGE AFN END CAP OS333003L OXBRIDGE AFN 4MM DRILL - LONG OS331104 OXBRIDGE AFN END CAP DIA 11MM X 10MM LONG OS330026 OXBRIDGE AFN 5MM X 26MM CORTICAL SCREW (Ti6Al4V) OS330030 OXBRIDGE AFN 5MM X 30MM CORTICAL SCREW (Ti6Al4V) OS331105 OXBRIDGE AFN END CAP DIA 12MM X 5MM LONG OS330070 OXBRIDGE AFN 5MM X 70MM CORTICAL SCREW (Ti6Al4V) OS330060 OXBRIDGE AFN 5MM X 60MM CORTICAL SCREW (Ti6Al4V) OS333016 OXBRIDGE ANKLE FUSION NAIL 3.9MM GUIDE PIN OS330120 OXBRIDGE AFN 5MM X 120MM CORTICAL SCREW (Ti6Al4V) OS330065 OXBRIDGE AFN 5MM X 65MM CORTICAL SCREW (Ti6Al4V) OS330024 OXBRIDGE AFN 5MM X 24MM CORTICAL SCREW (Ti6Al4V) OS330034 OXBRIDGE AFN 5MM X 34MM CORTICAL SCREW (Ti6Al4V) OS331107 OXBRIDGE AFN ENDCAP LOCKING OS333013 OXBRIDGE AFN DISPOSABLES - DRILLS/ PIN AND EXCHANGE TUBE OS330020 OXBRIDGE AFN 5MM X 20MM CORTICAL SCREW (Ti6Al4V) OS331103 OXBRIDGE AFN END CAP DIA 11MM X 5MM LONG OS330055 OXBRIDGE AFN 5MM X 55MM CORTICAL SCREW (Ti6Al4V) OS330045 OXBRIDGE AFN 5MM X 45MM CORTICAL SCREW (Ti6Al4V) OS332180N OXBRIDGE ANKLE FUSION NAIL 12MM X 180MM (Ti6Al4V) SynthaGen HaTCP MIS-1205-FO Apex ASG 966-1205 OsteoXcell BA OSBA-010M SynthaGen HaTCP OBS-1203-FO BioViveSBG 1DE-OBS-05 BioViveSBG 1DE-OBS-02 Apex ASG 965-1210 OsteoXcell BA OSBA-002 SynthaGen HaTCP OBS-1205-FO OsteoXcell BA OSBA-010 si-Mochi VET1210-M si-Mochi OBS1202 si-Mochi VET1210-O si-Miochi MIS1205 si-Mochi VET1203-O si-Mochi OBS1203 si-Mochi OBS1205 si-Mochi MIS1210 si-Mochi OBS1210 OsteoXcell BA OSBA-001 OsteoXcell BA OSBA-005M SynthaGen HaTCP OBS-1210-FO OsteoXcell BA OSBA-003 si-Mochi VET1202-O si-Mochi VET1205-O System 2 BA SYS210M System 2 BA SYS202 si-Mochi OBS1201 OsteoXcell BA OSBA-005 si-Mochi VET1205-M Apex ASG 965-1205 Apex ASG 965-1203 System 2 BA SYS205 si-Mochi VET1201-O Apex ASG 966-1210 BioViveSBG 1DE-OBS-10 BioViveSBG 1DE-MIS-10 Apex ASG 965-1201 SynthaGen HaTCP OBS-1201-FO BioViveSBG 1DE-OBS-01 System 2 BA SYS210 System 2 BA SYS205M SynthaGen HaTCP MIS-1210-FO BioViveSBG 1DE-OBS-03 SynthaGen HaTCP OBS-1202-FO BioViveSBG 1DE-MIS-05 Apex ASG 965-1202 System 2 BA SYS201 System 2 BA SYS203 249095000-13 LEGEND II Neoss Proactive Implant Proactive Implant House Curette, Double Ended 2/3mm Scoops, 180mm House Currette Total hip GLOBAL UNITE COLLAR SZ 52 ECC GLOBAL UNITE COLLAR SZ 52 GLOBAL UNITE BODY SZ 14 -5 GLOBAL UNITE COLLAR SZ 40 GLOBAL UNITE COLLAR SZ 44 ECC GLOBAL UNITE COLLAR SZ 48 ECC GLOBAL UNITE COLLAR SZ 56 GLOBAL UNITE COLLAR SZ 40 ECC GLOBAL UNITE BODY SZ 10 +5 GLOBAL UNITE BODY SZ 16 -5 GLOBAL UNITE BODY SZ 14 +5 GLOBAL UNITE BODY 16 +5 GLOBAL UNITE BODY SZ 10 0 GLOBAL UNITE COLLAR SZ 56 ECC GLOBAL UNITE BODY SZ 12 +5 GLOBAL UNITE COLLAR SZ 48 GLOBAL UNITE BODY SZ 12 0 GLOBAL UNITE BODY SZ 14 0 GLOBAL UNITE BODY SZ 12 -5 GLOBAL UNITE BODY SZ 10 -5 GLOBAL UNITE BODY SZ 16 0 GLOBAL UNITE COLLAR SZ 44 140720101 GLOBAL UNITE 140720103 GLOBAL UNITE 140720102 GLOBAL UNITE 101836500 Pinnacle Hip System 136533000 Pinnacle Hip System 136532000 Pinnacle Hip System 101836505 Pinnacle Hip System 136536000 Pinnacle Hip System 101836511 Pinnacle Hip System 136534000 Pinnacle Hip System 101836503 Pinnacle Hip System 101836508 Pinnacle Hip System 136555000 Pinnacle Hip System 136531000 Pinnacle Hip System 136526000 Pinnacle Hip System 10-116 Nasal Slimpack 10cm 10-125T Anatomical Slimpack with Tube 10-100 Nasal Pack - 4.5cm 11 002 Nasal Packing straight, with drawstring 10-111 Nasal slimpack - 8 cm 10-120 Anatomical Pack - 8cm 10-115 Nasal Pack 10cm 15110C Series 5000 Nasal Pack 8cm 10-110 Nasal Pack - 8cm 15-105 SERIES 5000 Single Hydration Nasal Pack - 6cm 10-106 Nasal Slimpack 6cm 20-211 Sinus Pack / Medium - 3.5cm 10-105T Nasal Pack with Tube - 6cm 10120T Anatomical Pack with Tube - 8cm 10111C Nasal Pack, with drawstring - 8cm 20-200 Sinus Pack / Standard 2.5cm 11 004 Nasal Packing straight, with drawstring and tube 10116L Nasal Pack, with draw string - 10cm 11 011 Nasal Packing straight, with drawstring with tube 10-125 Anatomical Slimpack - 8cm 11 010 Nasal Packing straight, with drawstring 15-110 SERIES 5000 Single Hydration Nasal Pack - 8cm 10111L Nasal Pack, with drawstring, multi-layered - 8cm 10-101 Nasal Slimpack - 4.5cm 11 015 Nasal Packing anatomically shaped, with drawstring and tube 20-212 Sinus Pack / Small - 3.5cm 20-210 Sinus Pack / Standard - 3.5cm 15-111 SERIES 5000 Single Hydration Nasal Slimpack - 8cm 10-111T Nasal Slimpack with Tube - 8cm 10-105 Nasal Pack 6cm 10101C Nasal Pack Classic, with drawstring 4.5cm 10-110T Nasal Pack with Tube - 8cm Nasal Pack Sinus Pack SAIPH Knee System C-Stem Schuknecht Pick Straight 160mm Pick 102354016 RECLAIM 102854526 RECLAIM 102354515 RECLAIM 101854020 RECLAIM 102854524 RECLAIM 102354517 RECLAIM 101854518 RECLAIM 101854514 RECLAIM 102354526 RECLAIM 101854013 RECLAIM 101854519 RECLAIM 102354018 RECLAIM 102354516 RECLAIM 101854513 RECLAIM 102354524 RECLAIM 102354017 RECLAIM 101854017 RECLAIM 101854521 RECLAIM 102354019 RECLAIM 102354521 RECLAIM 102354014 RECLAIM 101854512 RECLAIM 101854522 RECLAIM 102354520 RECLAIM 102354525 RECLAIM 102354518 RECLAIM 102854525 RECLAIM 102354020 RECLAIM 102354519 RECLAIM 102854519 RECLAIM 101854515 RECLAIM 101854021 RECLAIM 101854022 RECLAIM 101854019 RECLAIM 101854012 RECLAIM 101854516 RECLAIM 102354022 RECLAIM 102354514 RECLAIM 101854520 RECLAIM 102354015 RECLAIM 102854523 RECLAIM 102854518 RECLAIM 101854018 RECLAIM 101854014 RECLAIM 102854522 RECLAIM 102354523 RECLAIM 101854015 RECLAIM 101854016 RECLAIM 102854520 RECLAIM 101854517 RECLAIM 102354522 RECLAIM 102354021 RECLAIM 110006100 GLOBAL UNITE 110040120 GLOBAL UNITE 110012100 GLOBAL UNITE 110060100 GLOBAL UNITE 110050110 GLOBAL UNITE 110016100 GLOBAL UNITE 110020400 GLOBAL UNITE 110060110 GLOBAL UNITE 110008600 GLOBAL UNITE 110050120 GLOBAL UNITE 110060120 GLOBAL UNITE 110008100 GLOBAL UNITE 110020110 GLOBAL UNITE 110020210 GLOBAL UNITE 110020200 GLOBAL UNITE 110006600 GLOBAL UNITE 110040100 GLOBAL UNITE 110020300 GLOBAL UNITE 110020410 GLOBAL UNITE 110020500 GLOBAL UNITE Global Unite STD Stem Global Unite REV Stem 110030100 GLOBAL UNITE 110030120 GLOBAL UNITE 110014100 GLOBAL UNITE Global Unite Body Global Unite Collar 110020510 GLOBAL UNITE 110040110 GLOBAL UNITE 110030110 GLOBAL UNITE 110010600 GLOBAL UNITE 110012600 GLOBAL UNITE 110010100 GLOBAL UNITE 110020100 GLOBAL UNITE 110050100 GLOBAL UNITE 110020310 GLOBAL UNITE Neoss Proactive Tapered Implant DB10-0001 Infinitas Mini Implant - 1.5mmD, 6mmL, Short Neck, Standard Head DB10-0008 Infinitas Mini Implant - 2mmD, 9mmL, Long Neck, Standard Head DB10-0002 Infinitas Mini Implant - 1.5mmD, 9mmL, Short Neck, Standard Head DB10-0007 Infinitas Mini Implant - 2mmD, 6mmL, Long Neck, Standard Head DB10-0004 Infinitas Mini Implant - 1.5mmD, 9mmL, Long Neck, Standard Head OS380013 COGNiTiON 4 LEG STAPLE 25MM X 20MM OS380003 COGNiTiON 2 LEG STAPLE 20MM X 15MM OS380005 COGNiTiON 2 LEG STAPLE 25MM X 20MM OS380004 COGNiTiON 2 LEG STAPLE 20MM X 20MM OS380001 COGNiTiON 2 LEG STAPLE 10MM X10MM OS380011 COGNiTiON 4 LEG STAPLE 20MM X 15MM OS380002 COGNiTiON 2 LEG STAPLE 15MM X 15MM OS380012 COGNiTiON 4 LEG STAPLE 20MM X 20MM Total hip 101468000 Modular Femoral Heads 101467000 Modular Femoral Heads Cusco Specula Insulated with Smoke Tubes 121790062 PINNACLE 121792050 PINNACLE 121791062 PINNACLE 121791058 PINNACLE 121792060 PINNACLE 121792052 PINNACLE 121792064 PINNACLE 121791052 PINNACLE 121791066 PINNACLE 121793058 PINNACLE 121790052 PINNACLE 121791060 PINNACLE 121792048 PINNACLE 121792062 PINNACLE 121790050 PINNACLE 121790060 PINNACLE 121793066 PINNACLE 121793062 PINNACLE 121790048 PINNACLE 121791064 PINNACLE 121793052 PINNACLE 121793054 PINNACLE 121791056 PINNACLE 121792066 PINNACLE 121790064 PINNACLE 121791048 PINNACLE 121792058 PINNACLE 121790054 PINNACLE 121790058 PINNACLE 121791054 PINNACLE 121793056 PINNACLE 121793064 PINNACLE 121792054 PINNACLE 121793048 PINNACLE 121793050 PINNACLE 121791050 PINNACLE 121793060 PINNACLE 121790066 PINNACLE 121792056 PINNACLE 121790056 PINNACLE 122132048-14 PINNACLE ALTRX 122136054-14 PINNACLE ALTRX 122132050-19 PINNACLE ALTRX 122136052-14 PINNACLE ALTRX Neoss Various Titamum Abutments Titanium Abutments 10007 Quick-Start 10007R Quick-Start 10021 Quick-Start 10020 Quick-Start 10006 Quick-Start 10012 Quick-Start 10015 Quick-Start 10010 Quick-Start 10001 Quick-Start 10004R Quick-Start 10002R Quick-Start 10002 Quick-Start Quick-Start 10017 Quick-Start 10011 Quick-Start 10025 Quick-Start 10001R Quick-Start 10013 Quick-Start 10008 Quick-Start 10018 Quick-Start 10009 Quick-Start 10003R Quick-Start 10016 Quick-Start 10003 Quick-Start 10019 Quick-Start 10024 Quick-Start 10022 Quick-Start 10014 Quick-Start 10023 Quick-Start 10005 Quick-Start 10004 Quick-Start 122132064-14 PINNACLE ALTRX 122132066-14 PINNACLE ALTRX 122132060-14 PINNACLE ALTRX 122132062-14 PINNACLE ALTRX 122036558 DURALOC 122036464 DURALOC 122036460 DURALOC 122036458 DURALOC 122036456 DURALOC 122036564 DURALOC 122036556 DURALOC 122036566 DURALOC 122036462 DURALOC 122036560 DURALOC 122036562 DURALOC 122036554 DURALOC 122036454 DURALOC 122036466 DURALOC 159923048 Hip Product 159923058 Hip Product 159923052 Hip Product 159923062 Hip Product 159923054 Hip Product 101467000 101871000 101811000 101812000 Modular Femoral Heads 101814000 Modular Femoral Heads 101871000 Modular Femoral Heads 101875000 Modular Femoral Heads 101470000 101811000 Modular Femoral Heads 101468000 101875000 101813000 Total hip 101814000 101812000 101472000 101813000 Modular Femoral Heads 101471000 Neo Implant System Implant System Neo 121866055-11 PINNACLE Hip Solutions PINNACLE DM LINER 54_47 PINNACLE DM LINER 50_43 PINNACLE DM LINER 52_45 PINNACLE DM LINER 48_41 121858049-11 PINNACLE Hip Solutions 121854047-11 PINNACLE Hip Solutions 121850043-11 PINNACLE Hip Solutions 121864053-11 PINNACLE Hip Solutions 121856049-11 PINNACLE Hip Solutions 121860051-11 PINNACLE Hip Solutions 121862053-11 PINNACLE Hip Solutions 121852045-11 PINNACLE Hip Solutions 121848041-11 PINNACLE Hip Solutions System Delivery Allergen and Vaccine Kratz-Barraquer Eye Speculum 35 mm (Small) Eye Speculum 522022 S-ROM CKB2 Chiroklip 100372 SmartPeg Type 11 100559 SmartPeg Type 67 100716 SmartPeg Type 85 100811 SmartPeg Type 137 100361 SmartPeg Type 13 100412 SmartPeg Type 24 100442 SmartPeg Type 33 100782 SmartPeg Type 109 100472 SmartPeg Type 45 100747 SmartPeg Type 88 100479 SmartPeg Type 48 100810 SmartPeg Type 127 100370 SmartPeg Type 10 100404 SmartPeg Type 22 100440 SmartPeg Type 32 100447 SmartPeg Type 36 100544 SmartPeg Type 61 100380 SmartPeg Type 7 100497 SmartPeg Type 57 100771 SmartPeg Type 111 100363 SmartPeg Type A3 100487 SmartPeg Type 55 100744 SmartPeg Type 107 100766 SmartPeg Type 101 100768 SmartPeg Type 103 100541 SmartPeg Type 58 100402 SmartPeg Type 21 100478 SmartPeg Type 47 100545 SmartPeg Type 62 100484 SmartPeg Type 53 100674 SmartPeg Type 82 100751 SmartPeg Type 92 100579 SmartPeg Type 73 100376 SmartPeg Type 5 100756 SmartPeg Type 93 100444 SmartPeg Type 34 100432 SmartPeg Type 28 100543 SmartPeg Type 60 100714 SmartPeg Type 83 100411 SmartPeg Type 23 100353 SmartPeg Type 1 100765 SmartPeg Type 100 100485 SmartPeg Type 54 100743 SmartPeg Type 97 100671 SmartPeg Type 81 100374 SmartPeg Type 14 100558 SmartPeg Type 66 100749 SmartPeg Type 90 100390 SmartPeg Type 17 100781 SmartPeg Type 108 100557 SmartPeg Type 65 91072 SmartPeg Type 52 - Neoss 100581 SmartPeg Type 75 100388 SmartPeg Type 16 100481 SmartPeg Type 50 100758 SmartPeg Type 95 100431 SmartPeg Type 27 100634 SmartPeg Type 87 100368 SmartPeg Type 9 100715 SmartPeg Type 84 100780 SmartPeg Type 106 100757 SmartPeg Type 94 100769 SmartPeg Type 104 100350 SmartPeg Type 4 100584 SmartPeg Type 79 100448 SmartPeg Type 37 100477 SmartPeg Type 46 100580 SmartPeg Type 74 100425 SmartPeg Type 26 100355 SmartPeg Type 2 100357 SmartPeg Type 3 100717 SmartPeg Type 86 100809 SmartPeg Type 117 100612 SmartPeg Type 91 100359 SmartPeg Type 12 100555 SmartPeg Type 64 100554 SmartPeg Type 63 100415 SmartPeg Type 25 100561 SmartPeg Type 77 100483 SmartPeg Type 52 100366 SmartPeg Type 8 91071 SmartPeg Type 38 - Neoss 100583 SmartPeg Type 78 100378 SmartPeg Type 6 100560 SmartPeg Type 68 100436 SmartPeg Type 30 100576 SmartPeg Type 69 100398 SmartPeg Type 18 100764 SmartPeg Type 99 100446 SmartPeg Type 35 100582 SmartPeg Type 76 100759 SmartPeg Type 96 100670 SmartPeg Type 80 100438 SmartPeg Type 31 100767 SmartPeg Type 102 100748 SmartPeg Type 89 100462 SmartPeg Type 40 100386 SmartPeg Type 15 100455 SmartPeg Type 38 91073 SmartPeg Type 98 - Neoss 100482 SmartPeg Type 51 100770 SmartPeg Type 110 100480 SmartPeg Type 49 100466 SmartPeg Type 44 91070 SmartPeg Type 18 - Neoss OS292220-NS K-WIRE, TROCAR TIP 2MM X 200MM OS900091-NS COMPRESSION DISTRACTION DEVICE Stericut Stericut (Accessories: saw blades, drill bits, burs, dermatome blades) Suction Regulator, Stainless Steel with Improved Grip Suction Regulator Neoss Implant System Instructmets and Accessories ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS Lid Implant Eye Lid Implant Tuke Saw 873556 S-ROM 873557 S-ROM 875987 S-ROM 873435 S-ROM EZ-Tip (Vial of 20 and singles) EZ-Grip 961214500 C-STEM 961210500 C-STEM C-Stem 961210500-13 C-STEM 961214500-13 C-STEM 961212500-13 C-STEM 961216500 C-STEM 961212500 C-STEM 961246000 C-STEM 961218500 C-STEM 961218500-13 C-STEM 961220500 C-STEM 961216500-13 C-STEM 961246000-13 C-STEM Filshie Clip Filshie Clip System 522033 S-ROM 522030 S-ROM 522028 S-ROM 875954 S-ROM 522032 Modular Femoral Heads 522034 Modular Femoral Heads 875955 S-ROM 522028 Modular Femoral Heads 522034 S-ROM 522030 Modular Femoral Heads 875953 S-ROM 522029 S-ROM 522029 Modular Femoral Heads 875956 S-ROM 522032 S-ROM 522033 Modular Femoral Heads 857723 P.F.C. 962734000 ELITE Femoral Heads 962575000 ELITE Femoral Heads 962573000 ELITE Femoral Heads 961210500 Centralisers and C-Stem End Cap 962735000 ELITE Femoral Heads 962730000 ELITE Femoral Heads 961212500 Centralisers and C-Stem End Cap 962567000 ELITE Femoral Heads 962529000 ELITE Femoral Heads 962747000 ELITE Femoral Heads 961214500 Centralisers and C-Stem End Cap 961218500 Centralisers and C-Stem End Cap 962572000 ELITE Femoral Heads 962574000 ELITE Femoral Heads 961246000 Centralisers and C-Stem End Cap 961216500 Centralisers and C-Stem End Cap 962731000 ELITE Femoral Heads 30-315 Ear Wick / Fenestrated 24mm 30-305 Ear Wick / Fenestrated - 15mm 30315C Ear Wick, Fenestrated - 24mm 30300C Ear Wick - 15mm 30305C Ear Wick - Fenestrated - 15mm 30-300 Ear Wick - 15mm 30-310 Ear Wick 24mm 30340C Ear Pack, Classic - 12mm dia x 24mm 30-380 Microspheres / Small - 3mm 30310C Ear Wick Classic - 9mm dia x 24mm Ear Wick 122122041 BI-MENTUM ALTRX 122128053 BI-MENTUM ALTRX 122128057 BI-MENTUM ALTRX 122128055 BI-MENTUM ALTRX 122128059 BI-MENTUM ALTRX 122128049 BI-MENTUM ALTRX 122128067 BI-MENTUM ALTRX 122122045 BI-MENTUM ALTRX 122128063 BI-MENTUM ALTRX 122122043 BI-MENTUM ALTRX 122128065 BI-MENTUM ALTRX 122128047 BI-MENTUM ALTRX 122128051 BI-MENTUM ALTRX 122128061 BI-MENTUM ALTRX 122128069 BI-MENTUM ALTRX 151820116-14 ATTUNE 152020910-14 ATTUNE 152020306-14 ATTUNE 152020408-14 ATTUNE 152020108-14 ATTUNE 152020716-14 ATTUNE 152020310-14 ATTUNE 152020705-14 ATTUNE 151820514-14 ATTUNE 151820306-14ATTUNE 152020405-14 ATTUNE 152020416-14 ATTUNE 151820414-14 ATTUNE 152020508-14 ATTUNE 151821010-14 ATTUNE 151821005-14 ATTUNE 152020406-14 ATTUNE 151820805-14 ATTUNE 152020308-14 ATTUNE 151820314-14 ATTUNE 152021007-14 ATTUNE 152020707-14 ATTUNE 152020505-14 ATTUNE 152020712-14 ATTUNE 151820216-14 ATTUNE 151820614-14 ATTUNE 151821006-14 ATTUNE 151820910-14 ATTUNE 152020106-14 ATTUNE 151820808-14 ATTUNE 152020316-14 ATTUNE 152020114-14 ATTUNE 151820508-14 ATTUNE 151820705-14 ATTUNE 152020916-14 ATTUNE 151820212-14 ATTUNE 152020116-14 ATTUNE 151820606-14 ATTUNE 152020507-14 ATTUNE 152020714-14 ATTUNE 152020214-14 ATTUNE 152020212-14 ATTUNE 152020810-14 ATTUNE 152020210-14 ATTUNE 151820108-14 ATTUNE 151820208-14 ATTUNE 151821012-14 ATTUNE 151820812-14 ATTUNE 152020206-14 ATTUNE 152021012-14 ATTUNE 151820408-14 ATTUNE 151820806-14 ATTUNE 151820305-14 ATTUNE 151820908-14 ATTUNE 151820506-14 ATTUNE 151821008-14 ATTUNE 152020606-14 ATTUNE 151820907-14 ATTUNE 152020908-14 ATTUNE 152020605-14 ATTUNE 152020610-14 ATTUNE 151820906-14 ATTUNE 152021008-14 ATTUNE 152020407-14 ATTUNE 151820107-14 ATTUNE 151820106-14 ATTUNE 152020706-14 ATTUNE 151820406-14 ATTUNE 152020906-14 ATTUNE 152020305-14 ATTUNE 152020112-14 ATTUNE 151820316-14 ATTUNE 151820807-14 ATTUNE 152020312-14 ATTUNE 151820612-14 ATTUNE 151820407-14 ATTUNE 151820716-14 ATTUNE 152020216-14 ATTUNE 151820210-14 ATTUNE 151821016-14 ATTUNE 152020414-14 ATTUNE 151820516-14 ATTUNE 152021006-14 ATTUNE 152020110-14 ATTUNE 151820205-14 ATTUNE 152020607-14 ATTUNE 151820616-14 ATTUNE 151820112-14 ATTUNE 152020410-14 ATTUNE 152020806-14 ATTUNE 152020208-14 ATTUNE 152020808-14 ATTUNE 151820512-14 ATTUNE 151820312-14 ATTUNE 151820912-14 ATTUNE 152021005-14 ATTUNE 152020708-14 ATTUNE 152021010-14 ATTUNE 152020912-14 ATTUNE 151820510-14 ATTUNE 152020907-14 ATTUNE 152020107-14 ATTUNE 152020516-14 ATTUNE 151820607-14 ATTUNE 152020816-14 ATTUNE 151820914-14 ATTUNE 151820905-14 ATTUNE 152020510-14 ATTUNE 151820114-14 ATTUNE 152020710-14 ATTUNE 151820410-14 ATTUNE 151820810-14 ATTUNE 151821014-14 ATTUNE 152021016-14 ATTUNE 151820814-14 ATTUNE 151820505-14 ATTUNE 151820605-14 ATTUNE 152020205-14 ATTUNE 152020512-14 ATTUNE 151820105-14 ATTUNE 151820610-14 ATTUNE 152020814-14 ATTUNE 151820706-14 ATTUNE 151820707-14 ATTUNE 152020812-14 ATTUNE 152020914-14 ATTUNE 152020314-14 ATTUNE 151820416-14 ATTUNE 151820214-14 ATTUNE 152020307-14 ATTUNE 151820712-14 ATTUNE 151820308-14 ATTUNE 152020805-14 ATTUNE 152020616-14 ATTUNE 151820708-14 ATTUNE 152020105-14 ATTUNE 152020207-14 ATTUNE 151820405-14 ATTUNE 152020608-14 ATTUNE 151821007-14 ATTUNE 151820206-14 ATTUNE 152020412-14 ATTUNE 152020614-14 ATTUNE 152020506-14 ATTUNE 152020807-14 ATTUNE 151820207-14 ATTUNE 152020612-14 ATTUNE 151820412-14 ATTUNE 151820710-14 ATTUNE 152021014-14 ATTUNE 152020514-14 ATTUNE 151820110-14 ATTUNE 151820608-14 ATTUNE 151820310-14 ATTUNE 152020905-14 ATTUNE 151820714-14 ATTUNE 151820916-14 ATTUNE 151820307-14 ATTUNE 151820507-14 ATTUNE 151820816-14 ATTUNE 136515000 Modular Femoral Heads 101402500 Bantam 101480789 136514000 Modular Femoral Heads 101401500 101480790 P-Series Pump Kit DB10-0012 Infinitas Mini Implant - 1.5mmD, 9mmL, Long Neck, Standard Head DB10-0015 Infinitas Mini Implant - 2mmD, 6mmL, Long Neck, Standard Head DB10-0016 Infinitas Mini Implant - 2mmD, 9mmL, Long Neck, Standard Head DB10-0009 Infinitas Mini Implant - 1.5mmD, 6mmL, Short Neck, Standard Head DB10-0010 Infinitas Mini Implant - 1.5mmD, 9mmL, Short Neck, Standard Head Castroviejo Needle Holder with Lock 145mm Needle holder Mayo Hegar Needle Holder with groove, 130 mm Needle holder 853843 Hip Product 136518500 Pinnacle Hip System 853833 P.F.C. 853833 Hip Product 853843 P.F.C. 136517500 Pinnacle Hip System 853842 Hip Product 853841 P.F.C. 853831 Hip Product 853834 P.F.C. 853834 Hip Product 853831 P.F.C. 853841 Hip Product 853842 P.F.C. 136516500 Pinnacle Hip System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2012-12-12
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-11-20
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-11-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2021-10-16
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2025-11-20
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2025-11-20
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2022-10-24
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-11-20
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-11-20
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2025-11-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-12-12
MQH	Microtools, Assisted Reproduction (Pipettes)	Obstetrics/Gynecology	Class 2	884.6130	2012-12-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-12-12
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
KYD	Strip, Schirmer	Ophthalmic	Class 1	886.1800	2022-10-24
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2023-07-03
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-11-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-12-12
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-10-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-07-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2012-12-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2012-12-12
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2025-11-20
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2025-11-20
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2025-11-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-11-20
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-11-20
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-11-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-11-20
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2025-11-20
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-01-31
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-11-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2012-12-12
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2025-11-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2020-11-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-11-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-11-10
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-11-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2025-11-20
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2021-10-16
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-12-19
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2025-11-20
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-11-20
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2012-12-12
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2012-12-12
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2012-12-12
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2012-12-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-07-03
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2025-11-20
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-11-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2024-10-17
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-11-20
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-11-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-11-20
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-11-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2012-12-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-01-31
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-11-20
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-11-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-11-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-12-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-12-12
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2012-12-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2020-11-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2020-11-10
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2020-11-10
SCL	Allergen And Vaccine Delivery Needles	General Hospital	Class 2	880.5570	2022-10-24
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	2025-11-20
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2025-11-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-11-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-11-20
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-11-20
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2021-10-16
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2025-11-20
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2023-07-03
MML	Weights, Eyelid, External	Ophthalmic	Class 2	886.5700	2012-12-12
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2013-07-25
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2012-12-12
MQH	Microtools, Assisted Reproduction (Pipettes)	Obstetrics/Gynecology	Class 2	884.6130	2021-10-16
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
KNH	Laparoscopic Contraceptive Tubal Occlusion Device	Obstetrics/Gynecology	Class 3	884.5380	2012-12-12
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-11-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-11-20
LRN	Wire, Surgical	Orthopedic	Class 2	888.3030	2025-11-20
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2025-11-20
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2025-11-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2025-11-20
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2025-11-20
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-11-20
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-11-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-11-20
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2021-10-16
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-11-20
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-11-20
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2025-11-20
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-11-20
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2025-11-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-12
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2024-10-17
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2025-11-20
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2025-11-20
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2012-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

KEVIN WALLS Business: REGULATORY INSIGHT, INC. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

SWANN MORTON, LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9611194	SWANN MORTON, LTD.	SHEFFIELD, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K940328	Orthopaedic Innovations, Inc.	PRIME CEMENTED HIP SYSTEM	1995-04-07
K950761	Biomet, Inc.	INDEX ACETABULAT COMPONENT	1995-05-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008812251. Last updated year: 2026. Please use registration number 3008812251 when referencing this establishment in official correspondence.