Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003139373

FEI Number

3003139373

Entity Name

CELESTICA de MONTERREY S.A. de C.V.

City/State/Country

Apodaca Nuevo Leon, MX

Establishment Address

Calle Octava #102, Parque Industrial Monterrey, Apodaca Nuevo Leon 66600, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Celestica de Monterrey S.A. de C.V. (Owner Number: 10054863)

Owner / Operator Contact Address

Calle Octava #102, Parque Industrial Monterrey, Apodaca, MX-NLE 66600, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

JuggerLoc Bone to Bone Implant w/ Round SS button w/ Drills Kit JuggerLoc Bone to Bone Implant w/ Round TI button w/ Drills Kit 40MM NOPROFILE CANCEL SCREW 40MM NOPROF SELFTAP BICORT SCR WSHRLC FIX 18MM W/4 EXT SPIKES WASHERLOC (TM) MODIFIED AWL WASHERLOC TISSUE FIXATION 14MM WASHERLOC AWL GUIDE WASHERLOC COUNTERSINK WSHRLC FIX 16MM W/4 EXT SPIKES 65MM NOPROFILE CANCEL SCREW WLOC INSERTER-DRILL GUIDE 60MM NOPROFILE CANCEL SCREW 35MM NOPROFILE CANCEL SCREW 50MM NOPROFILE CANCEL SCREW 48MM NOPROF SELFTAP BICORT SCR 44MM NOPROF SELFTAP BICORT SCR WL TIBIAL DEPTH GAUGE 70MM NOPROFILE CANCEL SCREW 34MM NOPROF SELFTAP BICORT SCR 42MM NOPROF SELFTAP BICORT SCR 30MM NOPROFILE CANCEL SCREW 55MM NOPROFILE CANCEL SCREW 45MM NOPROFILE CANCEL SCREW 46MM NOPROF SELFTAP BICORT SCR 30MM NOPROF SELFTAP BICORT SCR 32MM NOPROF SELFTAP BICORT SCR 38MM NOPROF SELFTAP BICORT SCR 36MM NOPROF SELFTAP BICORT SCR NO-PROFILE 18MM FLAT WASHER 3/32 GUIDE PIN FOR FMRL AIMER 3/32 TROCAR TIP GUIDE PIN 16IN 8MM FEMORAL AIMER TIP DBL TUNNEL TIB GUIDE BULLET 3/32 MODULAR GUIDE WIRE CANNULATED BONE PLUG 5PK Leaf Sensor Implant Assembly Reload Mini Open Kit 3.5MM HEX SCREWDRIVER REVISION GENTLE THREAD SCRWDRV CANNULATED HEX SCREWDRVR 3.5MM SILS Port Flexible Port 5mm SILS Port Flexible Port 5mm-12mm DRILL POINT K-WIRE EZLOC DEPTH GAUGE PRECISION DEPTH GAUGE EXPRESSBRAID 10PK BLUE/WHITE EXPRESSBRAID SINGLE BLUE/WHITE EXPRESSBRAID 10PK WHITE EXPRESSBRAID SINGLE WHITE Surgineedle Auto Suture Insufflation Needle 120mm Surgineedle Auto Suture Insufflation Needle 150mm Long 7MM FEMORAL AIMER TIP 2MM NITINOL GUIDE WIRE 9 IN MODULAR GUIDE BULLET FANELLI GUIDE BULLET TIBIAL GUIDE CROSSPIN HOWELL 65 DEGREE TIBIAL GUIDE PRECISION GRAFT SIZING BLOCK LEFT PCL ARM RIGHT PCL ARM POINT & SHOOT BULLET MODULAR ACL GUIDE 9MM FEMORAL AIMER TIP HOWELL 65 DEGREE GUIDE BULLET 12MM FEMORAL AIMER TIP 13MM FEMORAL AIMER TIP 1.1MM NITINOL GUIDE WIRE 14 IN 1.5MM NITINOL GUIDE WIRE 14 IN POINT & SHOOT TIBIAL GUIDE 1.1MM NITINOL GUIDE WIRE 9 IN 2MM NITINOL GUIDE WIRE 14 IN LAA Selection Guide REV GEN THRD THREADED DILATOR GENTLE THREAD TUNNEL NOTCHER GENTLE THREADS SCREWDRIVER GENTLE THREADS TUNNEL DILATOR GENTLE THRD THREADED DILATOR EZ-OUT REMOVER COMPOSITCP 7-8MM 1.1 TAP 9MM MOD BIO-CORE TAP 8MM MOD BIO-CORE TAP 10MM MOD BIO-CORE TAP 7MM MOD BIO-CORE TAP 15 DEGREE ANGLED OSTEOTOME 9MM BTB CRIMPING PLIERS 9MM CAN DILATOR HEX DRIVER 7MM CAN DILATOR HEX DRIVER 10.5MM CAN DILATOR HEX DRIVER 8.5MM CAN DILATOR HEX DRIVER CANN DILATOR HANDLE HEX DRIVER 10MM CAN DILATOR HEX DRIVER COMPOSITCP MOD TAP 9-11MM 8MM CAN DILATOR HEX DRIVER 9.5MM CAN DILATOR HEX DRIVER 11MM CAN DILATOR HEX DRIVER 7.5MM CAN DILATOR HEX DRIVER BONE MULCH CURRETTE FEMORAL AIMER HANDLE UNIVERSAL RATCHET HANDLE OPEN ENDED TENDON STRIPPER CLOSED TENDON STRIPPER 30 DEG MICROFRACTURE 20 DEG MICROFRACTURE PICK 10 DEG MICROFRACTURE PICK 0 DEG MICROFRACTURE PICK FANELLI TUNNEL AWL WASHERLOC CORTICAL SCREW 40MM WASHERLOC CORTICAL SCREW 56MM 54MM 6MM CANCELLOUS SCREW WASHERLOC CORTICAL SCREW 50MM 44MM 6MM CANCELLOUS SCREW WASHERLOC CORTICAL SCREW 34MM 20MM NO-PROFILE TISSUE WASHER 26MM 6MM CANCELLOUS SCREW WASHERLOC CORTICAL SCREW 42MM 18MM NO-PROFILE TISSUE WASHER 14MM NO-PROFILE TISSUE WASHER 30MM 6MM CANCELLOUS SCREW 40MM 6MM CANCELLOUS SCREW WASHERLOC CORTICAL SCREW 48MM 36MM 6MM CANCELLOUS SCREW 52MM 6MM CANCELLOUS SCREW 58MM 6MM CANCELLOUS SCREW 42MM 6MM CANCELLOUS SCREW WASHERLOC CORTICAL SCREW 38MM WASHERLOC CORTICAL SCREW 58MM WASHERLOC CORTICAL SCREW 30MM WASHERLOC TISSUE FIXATION 16MM WASHERLOC CORTICAL SCREW 32MM WASHERLOC CORTICAL SCREW 60MM WASHERLOC CORTICAL SCREW 46MM WASHERLOC CORTICAL SCREW 36MM WASHERLOC TISSUE FIXATION 18MM 24MM 6MM CANCELLOUS SCREW WASHERLOC CORTICAL SCREW 44MM 32MM 6MM CANCELLOUS SCREW WASHERLOC CORTICAL SCREW 54MM 50MM 6MM CANCELLOUS SCREW 60MM 6MM CANCELLOUS SCREW 56MM 6MM CANCELLOUS SCREW 38MM 6MM CANCELLOUS SCREW 34MM 6MM CANCELLOUS SCREW 28MM 6MM CANCELLOUS SCREW WASHERLOC CORTICAL SCREW 52MM 48MM 6MM CANCELLOUS SCREW JUGGERKNOT Toggleloc XL With ZipLoop Inline Toggleloc XL With ZipLoop STERILE 3/32 IN GUIDE PIN FOR FEMORAL AIMER 5.5MM/6.8MM ALLTHREAD PUNCH 5.5MM ALLTHREAD FIXED TAP 6.8MM ALLTHREAD FIXED TAP MINI RC NEEDLE 24MM 2PK RC NEEDLE 35MM 2PK 6MM CANNULATED DRILL DRILL,4.5MM REUSE CANN TOGLOC ACL REV 2.5MM EASY OUT 5MM ALLTHREAD TI DRILL 7.5MM CANNULATED DRILL JGRKNT REUSE GUIDE 2.9 GRAY 3.2MM TWIST DRILL BIT 5 INCH 8.5MM CANNULATED DRILL 5.5MM CANNULATED DRILL 3.7MM CANNULATED DRILL ACL REV 2.5MM HEX BIT CANNULAT TOGGLELOC PUSHER EZLOC (TM) ETCHED DRILL PIN 7MM CANNULATED DRILL 9MM CANNULATED DRILL ACL REV 3.5MM HEX BIT CANNULAT 11MM CANNULATED DRILL 10MM CANNULATED DRILL 6.5MM CANNULATED DRILL 5MM CANNULATED DRILL 3.2MM CANNULATED DRILL 9.5MM CANNULATED DRILL 13MM CANNULATED DRILL TOGGLELOC (TM) DEPTH GAUGE 8MM CANNULATED DRILL 12MM CANNULATED DRILL 4.5MM CANN TOGGLE BUTTON DRILL 3.5MM HEX BIT NON-CANN 3/32 GUIDE PIN FOR FEMORAL AIMER, 25 PACK 2MM DRILL BIT JUGGERKNOT 1.4MM DISP KIT RGD SIZING SLEEVE 7MM IMPINGEMENT ROD 7MM SIZING SLEEVE 12MM ZIPLOOP PULLER FANELLI PCL OVR BCK CUPD CURET SIZING SLEEVE 9MM LOW PROFILE REAMER 9.5MM 7-8MM EZLOC SIZING STICK LOW PROFILE REAMER 10.5MM GRAFT SIZING BLOCK MEDIAL PORTAL AIMER 7MM SIZING SLEEVE 8MM MEDIAL PORTAL AIMER 10MM FANELLI CALIBRATED PROBE DBL BUNDLE FMRL AIMER 7MM POINT TO HOLE ACL GUIDE FANELLI PCL CUPPED CURETTE MEDIAL PORTAL AIMER 9MM FANELLI PCL OVR BCK OPN CURETT CURVED ROOFPLASTY GOUGE CURETTE 60 DEGREE SIZING SLEEVE 10MM IMPINGEMENT ROD 11MM MPF NITINOL SMALL GUIDE WIRE ACL GUIDE WIRE DISP KIT MEDIAL PORTAL AIMER 12MM FANELLI GUIDE SIZING SLEEVE 11MM IMPINGEMENT ROD 9MM POINT TO POINT ACL GUIDE RIGHT ANGLED CLAMP MEDIAL PORTAL AIMER 6MM 9-10MM EZLOC SIZING STICK IMPINGEMENT ROD 8MM IMPINGEMENT ROD 10MM LOW PROFILE REAMER 7.5MM PRECISION MPF AIMER HANDLE CRUCIATE SCREWDRIVER DBL BUNDLE FMRL AIMER 8MM GENTLE THREADS MODULAR SHAFT LOW PROFILE REAMER 7MM DBL BUNDLE FMRL AIMER 5MM MEDIAL PORTAL AIMER 11MM DISPOSABLE ZIPLOOP PULLER AC JOINT PROCEDURE SYSTEM MEDIAL PORTAL AIMER 8MM LOW PROFILE REAMER 9MM 11MM FEMORAL AIMER TIP FANELLI PCL CURVED RASP FANELLI PCL HOOK KNIFE FANELLI PCL OPEN CURETTE ANGLD DBL BUNDLE FMRL AIMER 10MM FANELLI PCL FANELLI MAGELLAN LOW PROFILE REAMER 8MM FEMORAL AIMER RING NUT LOW PROFILE REAMER 8.5MM 10MM FEMORAL AIMER TIP DBL BUNDLE FMRL AIMER 9MM 1.5MM NITINOL GUIDE WIRE 9 IN WASHERLOC REMOVER FANELLI PCL CAPSULE RASP DBL BUNDLE FMRL AIMER 6MM PRECISION SMALL GUIDE WIRE 5PK 3/32 MODULAR GUIDE WIRE 25 PACK LOW PROFILE REAMER 10MM 10MM DISPOSABL CORING TREPHINE 8MM DISPOSABLE CORING TREPHINE 11MM DISPOSABL CORING TREPHINE JUGGERLOC GUIDE WIRE 2.9MM SUTURE SHUTTLE KITE 7MM DISP DOWEL HARVEST TUBE 9MM DISPOSABLE CORING TREPHINE 10MM DISP DOWEL HARVEST TUBE 7MM DISPOSABLE CORING TREPHINE 8MM DISP DOWEL HARVEST TUBE 9MM DISP DOWEL HARVEST TUBE GNTL THREADS INT SCREW DIS KIT Disposable Cannula Kit ACL DISPOSABLE INST KIT TOGGLELOC/WASHERLOC DISP KIT EZLOC/WASHERLOC DISPOSABLE KIT JGRKNT 1.4MM SHORT REUSE GUIDE JUGGERKNOT SHRT DRILL BIT 1.4MM 1mm JuggerKnot Mini 3-0 w/ Tapered Needles 1mm JuggerKnot Mini 3-0 w/ Tapered Needles Multi Pack 1mm JuggerKnot Mini 2-0 w/ Tapered Needles Multi Pack 1mm JuggerKnot Mini 2-0 w/ Tapered Needles JGRKNT 1MM MINI STEP DRILL EZ PASS 45 DEGREE DOGLEG UP EZ PASS 70 DEGREE RIGHT EZ PASS 45 DEGREE UP EZ PASS 70 DEGREE LEFT EZ PASS 90 DEGREE UP EZ PASS 30 DEGREE LEFT EZ PASS 30 DEGREE RIGHT 10MM BTB CRIMPING PLIERS CALIBRATED PROBE ToggleLoc Fixation Device with Continuous Loop 35mm ToggleLoc Fixation Device with ZipLoop Technology AC Joint Repair Single ZipLoop Artificial Ligament Fixation Device #7 Ziploop Extended ToggleLoc Artificial Ligament Fixation Device BTB #7 Ziploop Extended ToggleLoc ToggleLoc with ZipLoop Elbow Implant #7 ToggleLoc Fixation Device with Continuous Loop 15mm ToggleLoc Fixation Device with ZipLoop Technology AC Joint Repair Double ZipLoop ToggleLoc Fixation Device with Continuous Loop 40mm Artificial Ligament Fixation Device Long #7 50 ZipLp Extended ToggleLoc ToggleLoc Fixation Device with Continuous Loop 45mm ToggleLoc Fixation Device with Continuous Loop 50mm ToggleLoc with ZipLoop Inline ToggleLoc Fixation Device with Continuous Loop 30mm ToggleLoc Fixation Device with Continuous Loop 20mm ToggleLoc Fixation Device with Continuous Loop 25mm NOPROFILE COUNTERSINK ZIPLOOP INLINE 2.9mm ToggleLoc w/Needles ZIPLOOP BUTTON 10MM 2.9mm ToggleLoc 6.5MM TI SCREW W/MAX BRAID 3MM TI W/ MAXBRAID NDLS 5MM TI W/ MAXBRAID NO NDLS 6.5MM TI W/ MAXBRAID NO NDLS 3MM TI W/ MAXBRAID SUTURE 5MM TI-SCREW ES 2 #2 MB W/NEEDLES Cory Knee Tensioner Cartridge Cory Knee tensioner PATELLA RETRACTOR Trocars (Versaport) LAA Exclusion System 7X30MM ROUND HEAD INT SCREW 8X30MM FULL THREAD INT SCREW 9X25MM ROUND HEAD INT SCREW 7X30MM FULL THREAD INT SCREW 9X20MM ROUND HEAD INT SCREW 10X20MM ROUND HEAD INT SCREW 10X25MM ROUND HEAD INT SCREW 8X20MM ROUND HEAD INT SCREW 7X20MM ROUND HEAD INT SCREW 8X30MM ROUND HEAD INT SCREW 7X20MM FULL THREAD INT SCREW 9X30MM ROUND HEAD INT SCREW 8X20MM FULL THREAD INT SCREW 9X25MM FULL THREAD INT SCREW 7X25MM FULL THREAD INT SCREW 8X25MM ROUND HEAD INT SCREW 7X25MM ROUND HEAD INT SCREW 9X30MM FULL THREAD INT SCREW 8X25MM FULL THREAD INT SCREW 9X20MM FULL THREAD INT SCREW 6X25MM ROUND HEAD INT SCREW JuggerKnotless Low Profile Reusable Obturator JuggerKnotless Low Profile Reusable Fishmouth Guide JUGGERKNOT JuggerKnotless Curved Single Loaded JuggerKnotless Low Profile Disposable Drill Bit JuggerKnotless Low Profile Reusable Guide JuggerKnotless Low Profile Reusable Trocar JuggerKnotless Curved Single Loaded 10 Pack JGRKNTLESS LOW PRO DISP KIT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-12-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-12-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-12-15
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2021-12-15
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2022-03-01
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-08-20
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2021-12-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-02-19
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2020-02-19
HWB	Extractor	Orthopedic	Class 1	888.4540	2022-06-16
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2021-12-15
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-02-28
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2017-06-30
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-12-15
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2021-12-23
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2021-12-15
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2021-12-15
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	2021-12-15
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2021-12-15
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2021-12-15
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-12-15
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2021-12-15
HWJ	Awl	Orthopedic	Class 1	888.4540	2021-12-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-04-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-04-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-12-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-01-27
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-27
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2022-06-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-12-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-12-23
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2022-04-25
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2021-12-13
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-12-15
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2021-12-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-02-21
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2020-08-24
HWQ	Passer	Orthopedic	Class 1	888.4540	2023-08-28
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-12-15
HXB	Probe	Orthopedic	Class 1	888.4540	2021-12-23
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-10-12
HWW	Countersink	Orthopedic	Class 1	888.4540	2021-12-15
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-01-27
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2021-12-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-12-23
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-12-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-12-23
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-01-24
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2021-12-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-06-27
PZX	Left Atrial Appendage Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2023-09-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-04-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-04-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-12-14
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

Payal Copling Email: payal.copling@celestica.com Phone: (469) 3953251

Related Public Records

Same Entity

Celestica de Monterrey S.A. de C.V.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003139373. Last updated year: 2026. Please use registration number 3003139373 when referencing this establishment in official correspondence.