INTERNATIONAL STERILIZATION LABORATORY, LLC

FDA Device Registration & Listing · GROVELAND, FL, US · Registration 1061927

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1061927
FEI Number
3000203000
Entity Name
INTERNATIONAL STERILIZATION LABORATORY, LLC
City/State/Country
GROVELAND, FL, US
Establishment Address
217 SAMPEY RD., GROVELAND, FL 34736, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
INTERNATIONAL STERILIZATION LABORATORY, LLC (Owner Number: 9051636)
Owner / Operator Contact Address
217 SAMPEY RD., --, Groveland, FL 34736, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-31
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2013-01-28
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2013-01-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-01-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-05-31
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-10-14
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
HQP Unit, Cautery, Thermal, Battery-Powered Ophthalmic Class 2 886.4115 2013-01-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2013-01-28
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-01-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2013-01-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-01-28
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-30
HQP Unit, Cautery, Thermal, Battery-Powered Ophthalmic Class 2 886.4115 2013-01-29
DRC Trocar Cardiovascular Class 2 870.1390 2023-05-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2023-05-30
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-05-30
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2023-05-30
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-01-21
PWY Lumbar Puncture Tray (Adult & Pediatric) General Hospital Class 2 880.5570 2024-05-06
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
LYS Bone Mill Orthopedic Class 1 888.4540 2023-07-19
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-07-13
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-01-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-03-06
HRX Arthroscope Orthopedic Class 2 888.1100 2023-03-06
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-01-21
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-10-14
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2020-12-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-30
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
KNG Monitor, Ultrasonic, Fetal Obstetrics/Gynecology Class 2 884.2660 2013-01-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-07-19
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-30
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-01-29
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-03-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-06-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-31
FSQ Light, Surgical, Instrument General, Plastic Surgery Class 2 878.4580 2013-01-29
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-29
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-01-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-10-14
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2023-05-30
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-28
FTF Illuminator, Non-Remote General, Plastic Surgery Class 2 878.4580 2013-01-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-03-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2016-01-21
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-01-11
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-29
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-05-30
OGD Custom Anesthesia Tray Anesthesiology Class 2 868.5120 2024-04-22
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2023-03-10
FKQ System, Dialysate Delivery, Central Multiple Patient Gastroenterology, Urology Class 2 876.5820 2013-04-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
HQP Unit, Cautery, Thermal, Battery-Powered Ophthalmic Class 2 886.4115 2013-01-29
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-01-28
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2013-01-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-03-06
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-01-30
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2013-01-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2017-06-21
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2023-07-13
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2024-05-06
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-01-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-01-21
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-29
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-28
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2013-01-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2013-01-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-01-21
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2013-01-30
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-07-19
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-07-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-04-02
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-04-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-04-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-11-30
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-07-11
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-07-13
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-30
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-07-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-11-30
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-07-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-03-10
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-30
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2013-01-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-31
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2013-01-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-30
HWQ Passer Orthopedic Class 1 888.4540 2016-01-22
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-01-21
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-01-11
DRC Trocar Cardiovascular Class 2 870.1390 2013-01-30
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-29
DTD Pacemaker Lead Adaptor Cardiovascular Class 2 870.3620 2013-01-30
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-01-15
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2013-01-29
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2023-05-30
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2025-04-15
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-05-31
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-05-06
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2023-07-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-28
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2023-05-31
HRX Arthroscope Orthopedic Class 2 888.1100 2023-05-31
HRX Arthroscope Orthopedic Class 2 888.1100 2013-01-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-28
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2021-08-27
HQP Unit, Cautery, Thermal, Battery-Powered Ophthalmic Class 2 886.4115 2013-01-29
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-07-28
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-01-30
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-30
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-29
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2023-03-29
OFU Spinal Anesthesia Kit Anesthesiology Class 2 868.5120 2024-04-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
DTD Pacemaker Lead Adaptor Cardiovascular Class 2 870.3620 2013-01-30
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-04-02
HAM Apparatus, Electrosurgical General, Plastic Surgery Class 2 878.4400 2013-01-29
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-07-19
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-05-31
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2013-01-30
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2013-01-28
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2023-07-28
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2025-08-05
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2023-05-30
HNJ Punch, Corneo-Scleral Ophthalmic Class 1 886.4350 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-01-15
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-29
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-07-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-04-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-01-17
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-01-28
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2013-01-28
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2013-01-28
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2013-01-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2025-03-31
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-06-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-01-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2013-01-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2008-12-29
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2013-01-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-07-19
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2013-01-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2024-04-18
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-10-14
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-05-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-31
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-05-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-01-30
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-01-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
DTD Pacemaker Lead Adaptor Cardiovascular Class 2 870.3620 2013-01-30
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-04-14
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-03-20
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-07-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-07-25
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2024-01-05
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-01-21
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2019-05-01
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-29
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-07-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
OFT Spinal Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2024-04-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-07-28
OGE Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2024-04-22
HRX Arthroscope Orthopedic Class 2 888.1100 2023-05-31
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2023-05-31
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2023-07-19
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-01-30
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-30
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-30
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2013-01-28
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2013-01-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-05-31
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2023-07-28
FTF Illuminator, Non-Remote General, Plastic Surgery Class 2 878.4580 2013-01-29
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-01-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-28
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-30
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-07-28
MCZ Suture Removal Kit General, Plastic Surgery Class 1 878.4800 2013-04-08
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-29
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2013-01-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-01-28
MNU Staple, Absorbable Orthopedic Class 2 888.3030 2013-01-28
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-28
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-30
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-01-30
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-04-14
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-01-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2013-01-29
GEE Brush, Biopsy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2013-04-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2013-01-28
OIL Discography Kit Radiology Class 2 892.1730 2024-04-18
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-01-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2013-01-28
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2013-01-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-29
SCL Allergen And Vaccine Delivery Needles General Hospital Class 2 880.5570 2023-02-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-10-14
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2021-12-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-12-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MNU Staple, Absorbable Orthopedic Class 2 888.3030 2013-01-28
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-05-30
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-05-30
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-07-11
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-01-15
FTF Illuminator, Non-Remote General, Plastic Surgery Class 2 878.4580 2013-01-29
OCJ Spinal Channeling Instrument, Vertebroplasty Orthopedic Class 1 888.4540 2023-05-31
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-04-09
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2013-01-30
QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact General Hospital Class 2 880.5860 2023-07-28
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-05-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-04-29
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2021-12-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-05-30
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-01-28

Official Correspondent

Steve Walter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INTERNATIONAL STERILIZATION LABORATORY, LLC
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
K203334 Acuitive Technologies, Inc. The Citrefix Knotless Suture Anchor 2021-02-05
K243467 Osteonic Co., Ltd. Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) 2024-12-03
K213415 OSSIO , Ltd. OSSIOfiber Suture Anchor 2022-03-28
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27

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 1061927. Last updated year: 2026. Please use registration number 1061927 when referencing this establishment in official correspondence.
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