FDA Device Registration & Listing · Santa Barbara, CA, US · Registration 3006990600
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FEI | Instrument, Special Lens, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2017-01-25 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-11-19 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2025-11-19 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 1996-08-07 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2007-08-23 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2020-05-01 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2007-08-23 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2013-12-31 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2008-11-26 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-04-14 |
| QHE | Shoulder Arthroplasty Implantation System | Orthopedic | Class 2 | 888.3660 | 2024-05-23 |
| IZI | System, X-Ray, Angiographic | Radiology | Class 2 | 892.1600 | 2025-11-19 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-19 |
| OWN | Confocal Optical Imaging | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-19 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-12 |
| IZI | System, X-Ray, Angiographic | Radiology | Class 2 | 892.1600 | 2021-07-23 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-07-23 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2007-08-23 |
| FWB | Camera, Television, Surgical, Without Audio | General, Plastic Surgery | Class 1 | 878.4160 | 2024-07-25 |
| OUG | Medical Device Data System | General Hospital | Class 1 | 880.6310 | 2017-12-13 |
| IZI | System, X-Ray, Angiographic | Radiology | Class 2 | 892.1600 | 2024-07-26 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-07-26 |
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | Class 1 | 878.4160 | 2017-01-25 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3031238646 | Arthrex Medical Device (Shanghai) Co. Ltd. | Shanghai, CN |
| 3007193505 | ARTHREX GMBH | Odelzhausen Bavaria, DE |
| 3013700547 | Arthrex Korea Ltd. | Gangnam-gu Seoul, KR |
| 3014004349 | Arthrex Singapore Pte Ltd. | Singapore Central Singapore, SG |
| 3020704423 | Arthrex New Zealand Limited | Auckland, NZ |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K193295 | Parcus Medical, LLC | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | 2020-01-23 |
| K193606 | Conmed Corporation | Y-Knot OneStep Anchor | 2020-01-22 |
| K984200 | R. Thomas Grotz, M.D., Inc. | STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE | 1999-01-21 |
| K171060 | Riverpoint Medical | OrthoButton AL | 2017-06-02 |
| K231867 | Paragon 28, Inc. | Grappler Suture Anchor System | 2023-08-21 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0009-2007 | Smith & Nephew Inc | 1 | Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. |
| Z-0010-2007 | Smith & Nephew Inc | 1 | Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486 |
| Z-0011-06 | Stryker Howmedica Osteonics Corp. | 1 | Allocraft TLIF Bone Inserter. |
| Z-0011-2007 | Smith & Nephew Inc | 1 | Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105 |
| Z-0013-2011 | Depuy Orthopaedics, Inc. | 1 | Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143
Catalog Number: 2570-00-000
The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 8043980 | Novanta Medical GmbH | LUDWIGSSTADT Bavaria, DE |
| 3003755939 | FARMACO QUIMICA NACIONAL, S.A. | La Esperilla Santo Domingo, DO |
| 3008720584 | Ovesco Endoscopy USA | Cary, NC, US |
| 3010041511 | Teleflex LLC (NADC) | Olive Branch, MS, US |
| 1220246 | ARTHREX, INC. | Naples, FL, US |
3006990600 when referencing this establishment in official correspondence.