STERILIZATION SERVICES OF GEORGIA, INC.

FDA Device Registration & Listing · ATLANTA, GA, US · Registration 1048735

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
1048735
FEI Number
1048735
Entity Name
STERILIZATION SERVICES OF GEORGIA, INC.
City/State/Country
ATLANTA, GA, US
Establishment Address
6005 BOATROCK BLVD., ATLANTA, GA 30336, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STERILIZATION SERVICES OF GEORGIA, INC. (Owner Number: 9002392)
Owner / Operator Contact Address
6005 BOATROCK BLVD., --, Atlanta, GA 30336, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TitanPort Vascular Access Port AMT BALLOON STOMA MEASURING DEVICE GUIDEWIRE COMPATIBLE BALLOON STOMA MEASURING DEVICE Electrode Tubing, irrigation, control MICRO G-JET Cable Bur Intravascular catheter Percutaneous Catheter AMT BALLOON GASTROSTOMY TUBE Tonsil Sponges Blade StarBurst XL Electrode Stimulator Percutaneous Catheter RITA Starburst Access System (11cm) Vortex VX Vascular Access Port Sheath Silicone sheet Laser shield EndoVive Standard Balloon Replacement Kit Right Angle Bolster Vent tube Myringotomy kit MINI ONE FEEDING SETS AMT CLAMP Tubing Decanters Patient drape Sheath Probe LifeValve Platinum Kit High pressure line Knife IntelliFlow Pump; Generator Acces.; Sortware Module; RFGenerator; Com Cable; MRI Ext. Cord; StarBurst Electrode Instrument wipe knob covers DECOMPRESSION TUBE Collector Closed fluid sets Surgical Mesh Triumph-1 Vascular Access Port MINI BALLOON BUTTON MINI ONE BALLOON BUTTON LifePort Vascular Access System Stent, superficial removal artery Prothesis SYRINGE ACCESSORY GUIDEWIRE ACCESSORY AMT G-JET Probe Tympanic membrane patcher Sheath Bone screw Arthroscope Electrode Shunt Prothesis Media and components, synthetic cell and tissue culture LifePort Vascular Access System Suction tubing Percutaneous Catheter Peanut Sponge GUYURON ENDOSCOPIC ACCESS DEVICE Irrigation system Drapes/Set-up covers Wilson Penile Implantation System TLC Self-Retaining Retractor System Wilson Scrotal Pack Probe LifePort Vascular Access System Wire, guide, catheter AMT INTRODUCER (GUIDEWIRE COMPATIBLE) Cherry Sponge O-arm Equipment Drape; Surgical drape and drape accessories Sheath Decanters Uro-catcher Syringes Applicator, absorbent tipped, sterile Needle, biopsy, cardiovascular Smart Port CT LifePort Vascular Access System UniBlate Electrosurgical AMT CAPSULE DOME GASTROSTOMY TUBE CAPSULE MONARCH GASTROSTOMY TUBE Y-PORT FEEDING ADAPTERS CAPSULE MONARCH GASTROSTOMY TUBE WITH GUIDEWIRE LifePort Vascular Access System StarBurst MRI Electrode LifePort Vascular Access System Tubing LifePort Infusion Set Fluid delivery sets Trach/Drainage Sponge Pre-attached subassembly Prothesis SurgiMesh WN G-JET Splint Endotrach tube Suction tip Phonoform LifePort Vascular Access System Tumor shaver MINIACE Prothesis NUTRAGLIDE NASAL FEEDING TUBE Probe AMT PEG-ASSIST INITIAL PLACEMENT KIT AMT INITIAL PLACEMENT DIATIOR SET Percutaneous Catheter Listing Number :D591479 AMT Balloon Measuring Device LifeValve Platinum Kit Fiberoptic device Tray, surgical, ent Pressure Monitoring Lines LifePort Vascular Access System Entuit Gastrostomy BR Balloon Retention Feeding Tube Tubing Spike Electrode ConvaTec Aquacel Ag Adhesive & Non-Adhesive Foam Wound Dressings Porcine Dermis (InteXen) Syringes Catheter Retriever D30 Plus Laser System; D15 Plus Laser System; EVLT Kit Angiographic waste bags Bone screw Habib 4X Laparoscopic Mesh, Surgical Percutaneous Catheter Irrigation set Elevate Biologic Assy. Post Pressure dressings Level 1 Foley Catheter with Temperature Sensor Cylindrical Sponges Vent tube LifePort Vascular Access System Decanters Small Port CT Kit, surgical instrument, disposable

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GXZ Electrode, Needle Neurology Class 2 882.1350 2019-11-04
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2019-11-04
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2013-01-22
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-04-30
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2013-03-28
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2013-03-28
GXZ Electrode, Needle Neurology Class 2 882.1350 2013-03-28
GXZ Electrode, Needle Neurology Class 2 882.1350 2019-11-04
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2013-03-28
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2013-03-28
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2013-03-28
HRX Arthroscope Orthopedic Class 2 888.1100 2013-03-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-04-30
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2019-11-04
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2013-03-28
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2013-03-28
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2013-03-28
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2013-03-28
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2023-03-16
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2023-03-16
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-04-30
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2013-03-19
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2013-03-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-25
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2013-03-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-03-16
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2023-03-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2013-01-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2013-03-28
MDA Elastomer, Silicone, For Scar Management General, Plastic Surgery Class 1 878.4025 2013-03-28
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-03-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2020-08-16
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2013-03-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-09-15
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2022-09-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2013-02-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2013-03-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-04-30
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2013-03-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-02-05
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-05
MNU Staple, Absorbable Orthopedic Class 2 888.3030 2013-02-05
KPE Container, I.V. General Hospital Class 2 880.5025 2013-01-22
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2013-01-22
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2013-03-28
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2020-08-17
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2020-08-17
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2013-03-28
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2013-01-25
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2013-01-22
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 2013-03-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-01-03
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2013-03-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic General, Plastic Surgery Class 1 878.4700 2012-11-06
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2022-09-15
KGC Tube, Gastro-Enterostomy Gastroenterology, Urology Class 2 876.5980 2024-04-30
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2013-01-24
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2013-03-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2013-02-05
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2019-11-07
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-01-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2022-09-15
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2013-02-05
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2013-02-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2013-01-25
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-04-30
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2013-02-22
ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat Class 2 874.3495 2013-03-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-04-30
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2013-03-28
KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) Ear, Nose, Throat Class 2 874.3620 2013-03-28
EOX Esophagoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4710 2013-03-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
LRK Device, Anti-Snoring Dental Class 2 872.5570 2013-03-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-02-05
HRX Arthroscope Orthopedic Class 2 888.1100 2013-03-28
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2013-03-28
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2013-03-28
ESZ Tube, Shunt, Endolymphatic Ear, Nose, Throat Class 2 874.3820 2013-03-28
ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat Class 2 874.3495 2013-03-28
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2013-03-28
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2013-01-22
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2019-11-07
KIT Media And Components, Synthetic Cell And Tissue Culture Hematology Class 1 864.2220 2013-01-23
FMF Syringe, Piston General Hospital Class 2 880.5860 2013-02-05
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2026-01-29
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2013-01-23
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-03-16
EFQ Gauze/Sponge, Internal Unknown Class U N/A 2013-03-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-04-30
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2013-03-28
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2013-03-28
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2013-01-22
GAD Retractor General, Plastic Surgery Class 1 878.4800 2024-05-06
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2013-03-28
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2013-03-28
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2013-03-28
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2013-01-22
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2022-09-15
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-02-05
FMF Syringe, Piston General Hospital Class 2 880.5860 2019-11-04
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2019-11-04
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-01-23
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-04-30
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2019-11-04
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2013-03-19
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2024-12-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
BYZ Trap, Sterile Specimen General Hospital Class 2 880.6740 2022-09-15
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2013-03-28
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2022-09-15
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2013-01-22
IWR Holder, Syringe, Lead Radiology Class 1 892.6500 2019-11-07
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2013-01-22
FMF Syringe, Piston General Hospital Class 2 880.5860 2013-01-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2013-01-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
DWO Needle, Biopsy, Cardiovascular General, Plastic Surgery Class 1 878.4800 2013-01-23
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-01-25
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-01-03
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-04-30
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-05
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2013-02-05
FOC Bag, Urine Collection, Newborn Gastroenterology, Urology Class 2 876.5250 2013-01-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-25
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2013-03-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-01-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-01-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2013-01-22
EFQ Gauze/Sponge, Internal Unknown Class U N/A 2013-03-19
OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed Obstetrics/Gynecology Class 3 884.5980 2013-01-24
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2013-01-24
ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat Class 2 874.3495 2013-03-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2022-09-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2013-03-28
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2013-03-28
FOD Device, Occlusion, Umbilical General Hospital Class 1 880.5950 2013-01-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-03-28
KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) Ear, Nose, Throat Class 2 874.3620 2013-03-28
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2013-03-28
EXD Irrigator, Ostomy Gastroenterology, Urology Class 2 876.5895 2024-04-30
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-04-30
ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat Class 2 874.3495 2013-03-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-04-30
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2013-03-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-04-30
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2023-03-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-03-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-05
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2026-01-29
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2019-11-07
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2013-01-22
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2026-04-30
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
MNU Staple, Absorbable Orthopedic Class 2 888.3030 2013-02-05
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2013-02-22
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2013-02-22
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2013-03-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-02-22
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2013-02-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
MMO Tray, Surgical, Ent Ear, Nose, Throat Class 1 874.4420 2013-01-23
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2013-01-22
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2020-08-16
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2013-03-28
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2013-03-28
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2013-02-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2013-03-28
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2013-03-28
GXZ Electrode, Needle Neurology Class 2 882.1350 2013-03-28
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2013-02-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2020-08-16
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2020-08-16
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-12-13
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-02-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
PAJ Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2013-01-24
PAI Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed Obstetrics/Gynecology Class 3 884.5980 2013-01-24
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2013-01-24
PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2013-01-24
KPE Container, I.V. General Hospital Class 2 880.5025 2013-01-22
FMF Syringe, Piston General Hospital Class 2 880.5860 2013-01-22
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2023-03-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-05
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2014-01-03
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2013-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-05
LRK Device, Anti-Snoring Dental Class 2 872.5570 2013-03-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-25
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-02-05
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2013-02-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-02-05
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2023-03-16
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2013-03-28
PAI Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed Obstetrics/Gynecology Class 3 884.5980 2013-01-24
OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed Obstetrics/Gynecology Class 3 884.5980 2013-01-24
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2013-01-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-02-05
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2020-08-16
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2013-03-19
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2013-01-22
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2013-03-28
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-01-22
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2026-01-29
KPE Container, I.V. General Hospital Class 2 880.5025 2013-01-22
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-25
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2013-01-23

Official Correspondent

Timothy Connor

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERILIZATION SERVICES OF GEORGIA, INC.
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
K033769 Howmedica Osteonics Corp. EIUS UNICOMPARTMENTAL KNEE SYSTEM 2004-02-13
K771511 3M Company TOTAL KNEE PROSTHESIS-NONCONSTRAINED 1977-11-30
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23

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 1048735. Last updated year: 2026. Please use registration number 1048735 when referencing this establishment in official correspondence.
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