FDA Device Registration & Listing · Fort Wayne, IN, US · Registration 3008864603
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-17 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-17 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2017-02-03 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-05-09 |
| HDA | Forceps, Obstetrical | Obstetrics/Gynecology | Class 2 | 884.4400 | 2016-09-21 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2016-11-17 |
| HCZ | Forceps, Surgical, Gynecological | Obstetrics/Gynecology | Class 2 | 884.4530 | 2016-09-21 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2018-05-30 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2016-09-21 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2021-07-02 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-21 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-21 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2017-03-13 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2016-05-09 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2016-05-09 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2016-05-09 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2016-09-21 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2018-03-28 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2016-11-16 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-25 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-25 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 8010372 | Instrumed GmbH dba Avalign German Specialty Instruments | TUTTLINGEN Baden-Wurttemberg, DE |
| 1527105 | AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC | Mentor, OH, US |
| 1421101 | Instrumed International Inc dba Avalign German Specialty Instruments | SCHAUMBURG, IL, US |
| 3004215117 | MILLENNIUM SURGICAL CORP | Schaumburg, IL, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| K243425 | Talladium España, SL | Guided DAS Surgical Kit | 2025-07-22 |
| K213209 | K1 Medical, LLC | EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device | 2021-12-28 |
| K012105 | Symmetry Medical, Inc. | POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM | 2002-08-02 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2016 | Zimmer, Inc. | 1 | Zimmer Universal Locking System, Titanium 3.5mm.
Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices. |
| Z-0027-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures. |
| Z-0028-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures. |
| Z-0029-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled
(2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures. |
| Z-0031-06 | Rita Medical Systems | 2 | Rita Brand Habib 4X Electrosurgical Coagulator,
Catalog Number: 4401US;
Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004358587 | HURON TOOL & CUTTER GRINDING | Farmingdale, NY, US |
| 3023809973 | RUSUN MEDICAL CO., LTD | Yichun City Jiangxi, CN |
| 3008496217 | DERMATO PLASTICA BEAUTY CO., LTD. | Kaohsiung City, TW |
| 3001614464 | medi-G GMBH | Messkirch Baden-Wurttemberg, DE |
| 3028006458 | ClearPoint Neuro Inc. | Carlsbad, CA, US |
3008864603 when referencing this establishment in official correspondence.