Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2648623

FEI Number

2648623

Entity Name

STERIS ISOMEDIX PUERTO RICO, INC.

City/State/Country

Alts De Cerro Gordo 3&4, PR, US

Establishment Address

KM 1 7, STATE Road, 690, BARRIO SABANA HOYOS, Alts De Cerro Gordo 3&4, PR 00692, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIS Corporation (Owner Number: 1527821)

Owner / Operator Contact Address

5960 Heisley Rd, --, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

StrykerPR3324 (VG) - Balloon Catheters 8G 15MM, 8G 20MM, 10G 10MM, 10G 15MM, 10G 20MM, 11G 10MM, 11G 15MM StrykerPR3324 (GR, LS, VG) - 10 G Bone Biopsy kit StrykerPR3324 (GR, LS, VG) - iVAS Bone Biopsy Kit 10G, 11G, 13G StrykerPR3324 (GR) - 10 G Bone Biopsy kit StrykerPR3324 (GR,VG) - 8 Gauge Biopsy StrykerPR3324 (GR,VG) - 13G Bone Biopsy Kit StrykerPR3324 (GR,VG) - 9" 10G Bone Biopsy Kit StrykerPR3324 (GR, LS, VG) - 11G Bone Biopsy Kit StrykerPR3324 (GR,VG) - 10G Biopsy Kit BardPR3770 (VG) - OptiFix Absorbable Fixation System StrykerPR3324 (GR, VG) - Omega PEEK Knotless Anchor System StrykerPR3324 (GR, VG) - OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, SINGLE OmegaSurgical (LSRTC) - BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Zimmer (LN) - blade, saw, general and plastic surgery, surgical StrykerPR3324 (GR, LS, VG) - PKG ,ENT IRR.AGG.SHAVER BLADE StrykerPR3324 (GR, LS, VG) - SJ Cutter Mnscs StrykerPR3324 (GR, LS, VG) - Cutter Meniscus StrykerPR3324 (GR) - 4 mm ENT MicroDebrider AGGRESSIVE SERRATED StrykerPR3324 (GR, LS, VG) - Cutter Full Radius StrykerPR3324 (GR, LS, VG) - Bur TMJ 2mm StrykerPR3324 (GR, LS, VG) - Bur TMJ 3mm StrykerPR3324 (GR, LS, VG) - SJ Cutter StrykerPR3324 (GR, LS) - 4mm Aggressive Serrated StrykerPR3324 (GR, LS, VG) - SHARPEDGE SHAVER BLADE 4MM StrykerPR3324 (VG) - Full Radius Cutter, Arthroscopic Shaver Blade StrykerPR3324 (VG) - Hooded Abrasion Bur, Arthroscopic Shaver Blade StrykerPR3324 (VG) - Aggressive Cutter, Arthroscopic Shaver Blade OrchidUnique5936 (LN) - Blade, Saw, General & Plastic Surgery, Surgical - Signature Series UltraLite StrykerPR3324 (VG) - ACM system with cancellous StrykerPR3324 (VG) - iVAS Bone Biopsy Kit 8G StrykerPR3324 (GR, LS, VG) - STRYKER AHTO TUBE SET PACKAGING Stryker3324 (GR, LS, VG) - STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING StrykerPR3324 (GR, LS, VG) - STRYKER AHTO TUBE SET WITH TIP PACKAGING StrykerPR3324 (GR, LS, VG) - Ahto Cassette Tube Set StrykerPR3324 (GR, LS, VG) - Ahto Cassette Tube Set with tip StrykerPR3324 (GR, LS, VG) - Ahto Cassette Tube Set With Y Connector StrykerPR3324 (GR, LS, VG) - Ahto Dual Spike Cassette Tube Set StrykerPR3324 (GR,VG,LN) - Bioprep Cement Restrictor KeySurgical6941 (LS) - Vascular Loops Syntech7829 (NT) - The Ahn Tray/ Ahn Tray StrykerPR3324 (GR, LS) - 8 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 6.5mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5mm X 90mm Threaded Cannula StrykerPR3324 (GR, LS, VG) - CANNULA PLUG StrykerPR3324 (GR, LS) - 5 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 6.5mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 8mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 5mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 8mm X 90mm Threaded Cannula StrykerPR3324 (GR, LS) - 5mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 8 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 5 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 8mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 5mm X 90mm Threaded Cannula Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 45mm Threaded Smith&Nephew3754 (NR) - CLEAR-TRAC Disposable Scope/Shaver Cannula, with Distal Rib Smith&Nephew3754 (NR) - Fixation Post, 5mm x 30mm Smith&Nephew3754 (NR) - DISP KNIFE ROSSETTE 3MM STR(5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 7mm x 72mm, Threaded Smith&Nephew3754 (NR) - SUTURE Threaders Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 45mm, Threaded Smith&Nephew3754 (NR) - ACUFEX Clear.Trac Threadedd.10 IDx76 LTX(10) Smith&Nephew3754 (NR) - DISPOSABLE KNIFE V SHAPED Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 35mm Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 8mm LTX Free (10) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 6.5 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 90mm, Threaded Smith&Nephew3754 (NR) - DISPOSABLE KNIFE HOOK 3MM (5) Smith&Nephew3754 (NR) - Split Cannula Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 4.5mm x 72mm, Threaded Smith&Nephew3754 (NR) - CLEAR-TRAC Disposable Scope/Shaver Cannula, Smooth Smith&Nephew3754 (NR) - TRANSPORTER (BOX 4) STERILE Smith&Nephew3754 (NR) - Clear-Trac Thrd Cann 5mm/76mm LTX Free (10) B Smith&Nephew3754 (NR) - Endoscopic Cann.Drill.Bit 4.5mm Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 90mm Threaded Smith&Nephew3754 (NR) - Fixation Post, 5mm x 40mm Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 6.5 x 72mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 7mm x 72mm, Smooth Smith&Nephew3754 (NR) - Univ Cannula 5mm/76mm LTX Free (10) Blue Smith&Nephew3754 (NR) - 3.8mm Tapered Awl, Disposable Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 9mm LTX Free (10) Smith&Nephew3754 (NR) - DISPOSABLE KNIFE SERRATED (5) Smith&Nephew3754 (NR) - PCL Safety Guidewire, 2.4mm x 25cm Smith&Nephew3754 (NR) - Guide Wire, 1.2mm x 12 (Box 5) Smith&Nephew3754 (NR) - Guide Wire, 1.2mm x 9 (Box 5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 4.5 x 72mm Threaded Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 30mm Smith&Nephew3754 (NR) - MENISCUS MENDER II DISPOSABLE Smith&Nephew3754 (NR) - Clear-Trac Complete Hip Cannula Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 5.5mm x 45mm, Threaded Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 7mm LTX Free (10) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 55mm Threaded Smith&Nephew3754 (NR) - DISPOSABLE KNIFE SHARP TIP Smith&Nephew3754 (NR) - Flexible Passing Pin, 13.50 X 2.4mm (Qty 5) Smith&Nephew3754 (NR) - SUTURE PASSER 2 STERILE Smith&Nephew3754 (NR) - Passing Pin, Drill Tip, 2.4mm x 15 Smith&Nephew3754 (NR) - DISP KNIFE SERRATED FLAT(BX 5) Smith&Nephew3754 (NR) - Clear-Trac Threaded Cann 8mm/76mm LTX Free (10) G Smith&Nephew3754 (NR) - (6) Guidewire 2mm x 15 Smith&Nephew3754 (NR) - Univ Cannula 7mm/76mm LTX Free (10) Green Smith&Nephew3754 (NR) - (5) Guidewire, 1.2mmx 18 (46 cm) Smith&Nephew3754 (NR) - Fixation Post, 5mm x 35mm Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 25mm Smith&Nephew3754 (NR) - SUTURE PASSER 12 STERILE Smith&Nephew3754 (NR) BONE TUNNEL PLUG CANN 7-12MM LTX FREE (6 Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 72mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 72mm, Threaded Smith&Nephew3754 (NR) - Fixation Post, 5mm x 25mm Smith&Nephew3754 (NR) - Clear-Trac Complete Stopcock Valve Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 40mm Smith&Nephew3754 (NR) - DISP KNIFE ROUND TIP (BX 5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 55mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 5.5mm x 72mm, Threaded Conmed (SX) - FENESTRATED CANNULA StrykerPR3324 (GR,LS, VG) - Strykeflow Single Spike Tube Set StrykerPR3324 (GR, LS, VG) - PKG., STRYKEFLOW SUCTION/IRRIGATOR PS StrykerPR3324 (VG,GR) - StrykeFlow PS StrykerPR3324 (VG,GR) - Strykeflow Single Spike Tube Set StrykerPR3324 (VG) - Autoplex Zimmer (LN,LS) - Bit, drill StrykerPR3324 (GR, LS, VG) - Twinloop FLEX TM Drill StrykerPR3324 (GR, LS, VG) - TwinLoop FLEX Zimmer (LN,LS) - Cannulated toggle button drill 4.5 MM Zimmer (LN,LS) - Maxfire Zimmer (LN,LS) - Toggleloc Eagle1350 (NT,SN) - Drill OmegaSurgical (LSRTC) - BIT, DRILL OrchidUnique5936 (LN) - Bit, Drill - Omega BardPR3770 (VG) - Sorbafix Absorbable Fixation System StrykerPR3324 (GR, VG) - AHTO SUCTION/IRRIGATION DUAL SPIKE TUBE SET StrykerPR3324 (GR, VG) - STRYKEFLOW2 WITH DISPOSABLE TIP (6BX) StrykerPR3324 (GR, VG) - PKG.SINUFLOW SUCTION/IRRIGATOR StrykerPR3324 (GR, VG) - AHTO SUCTION/IRRIGATION TUBE SET (6BX) StrykerPR3324 (GR, VG) - AHTO SUCTION/IRRIGATION TUBE SET WITH DISPOSABLE TIP (6BX) StrykerPR3324 (VG) - STRYKER TITANIUM CROSS SCREW SYSTEM StrykerPR3324 (GR, LS, VG) - PKG.40 DEG ANGLED CONVEX StrykerPR3324 (GR, LS, VG) - IRR JAGUAR CUTTER 3.5MM StrykerPR3324 (GR, LS, VG) - IRR JAGUAR CUTTER 4MM StrykerPR3324 (GR, LS, VG) - PKG.IRR.AGG.MENISCUS CUTTER StrykerPR3324 (VG) - 5MM X 75MM DRI-LOK CANNULA DISTAL THREAD StrykerPR3324 (VG) - 6.5MM X 90MM DRI-LOK THREADED CANNULA StrykerPR3324 (VG) - 8MM X 75MM DRI-LOK CANNULA DISTAL THREAD StrykerPR3324 (VG)- 6.5MM X 75MM DRI-LOK CANNULA DISTAL THREAD StrykerPR3324 (VG) - 8MM X 75MM NON-THREADED DRI-LOK CANNULA (5BX) StrykerPR3324 (VG) - 5MM X 75MM THREADED DRI-LOK CANNULA (5BX) StrykerPR3324 (VG) - 5MM X 75MM NON-THREADED DRI-LOK CANNULA (5BX) StrykerPR3324 (VG) - 6.5MM X 75MM THREADED StrykerPR3324 (VG) - 5MM X 90MM DRI-LOK CANNULA DISTAL THREAD StrykerPR3324 (VG) - 6.5MM X 90MM DRI-LOK CANNULA DISTAL THREAD StrykerPR3324 (VG) - 5MM X 90MM DRI-LOK THREADED CANNULA StrykerPR3324 (VG) - 8MM X 90MM DRI-LOK CANNULA DISTAL THREAD StrykerPR3324 (VG) - 8MM X 90MM DRI-LOK THREADED CANNULA StrykerPR3324 (VG) - 6.5MM X 75MM NON-THREADED DRI-LOK CANNULA (5BX) Ecomed7308 (LN) - Sureglide LSO2556 (NT) - C Safe StrykerPR3324 (LN,VG) - Universal ACL Instrumentation System MedtronicPR2690 (VG) - Marinr Steerable Intracardiac Electrode Catheter MedtronicPR2690 (VG) - StableMapr Steerable Intracardiac Electrode Catheter BardPR3770 (VG) - OptiFix Open Absorbable Fixation System BardPR3770 (VG) - OptiFix AT Absorbable Fixation System with Articulating Technology StrykerPR3324 (GR, LS, VG) - Krackow Press. StrykerPR3324 (VG) - iVAS Hand Drill Ranfac3098 (NR) - Access Needle, Ranfac Bone Access Needle, Ranfac Access Needle Kimball7603 (LN) - Curette 11G Ranfac3098 (NR) - Bone Access Needle Kimball7603 (LN) - Curette 10G StrykerPR3324 (VG) - CinchLock Flex MedtronicPR2690 (VG) - Torqr Intracardiac Electrode Catheter MedtronicPR2690 (VG) - Soloist Intracardiac Electrode Catheter StrykerInstruments (LS) - iVAS 8 GAUGE HAND DRILL StrykerInstruments (LS) - iVAS 8 Gauge Access Cannula StrykerInstruments (LS) - 10 Gauge Hand Drill Sterile StrykerInstruments (LS) - iVAS 8G Bevel Stylet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2020-10-19
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2020-10-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-04-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-04-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-04-24
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-12-14
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2012-12-18
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-09-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-12-12
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-09-11
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-09-11
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-09-11
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-09-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-09-11
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-09-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-09-30
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2013-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-10-25
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-10-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-10-25
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2020-10-19
LZN	Cement Obturator	General, Plastic Surgery	Class 2	878.3300	2020-10-19
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2020-10-19
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2012-11-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-05-06
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-05-06
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-05-06
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2012-12-20
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2012-12-18
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2012-12-18
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2012-12-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-12-06
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-12-06
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-12-06
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-12-06
LZN	Cement Obturator	General, Plastic Surgery	Class 2	878.3300	2012-12-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-12-18
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-01-08
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2019-04-03
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2012-12-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-18
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-11-16
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2012-11-07
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2020-10-19
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2020-10-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-03-24
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2023-08-22
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-12-27
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2012-11-06
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2012-12-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-07-31
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-07-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-07-31
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2022-07-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-07-31
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2020-10-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-12-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-12-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-12-19
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2012-12-27
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-03-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-03-24
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-03-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-03-24
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2012-12-18
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2023-08-22
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-12-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-12-14
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2020-10-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-12-06
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-12-06
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-12-06
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-12-06
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2020-10-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-03-24
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2012-12-27
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-01-08
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2012-11-07
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-09-06
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-10-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-10-24
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2023-10-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-10-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-10-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-10-24
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-11-08
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2012-11-08
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2012-11-08
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2012-11-08
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2012-11-08
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2012-11-08
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2012-11-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-12-15
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-12-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-12-19
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2023-12-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-12-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-12-19
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2014-08-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2014-08-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-08-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-08-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-08-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-08-28
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-09-06
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	General, Plastic Surgery	Class 3	878.4490	2013-03-08
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2012-11-15
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-11-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-11-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-11-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-11-21
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2012-12-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-10-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-10-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-10-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-10-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-10-24
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2012-11-07
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	Class 1	888.4540	2020-10-19
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2023-09-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-09-11
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2023-03-24
HDH	Needle, Cerclage, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2023-08-22
MCN	Barrier, Absorbable, Adhesion	Unknown	Class 3	N/A	2012-11-08
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-12-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-09-30
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-10-19
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2023-09-13
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-12-18
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2012-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation

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

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

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3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2648623. Last updated year: 2026. Please use registration number 2648623 when referencing this establishment in official correspondence.