GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
FDA 510(k) clearance K983814 · decided 1999-01-14
Clearance details
- K-number
- K983814
- Device name
- GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
- Applicant
- Efratgo, Ltd. HI Tech Bio-Surgical
- Decision
- Substantially Equivalent
- Date received
- 1998-10-28
- Decision date
- 1999-01-14
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- JDO
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OsteoCentric Integrated Hip Fastener System (K230764) | OsteoCentric Technologies | 2023-04-18 |
| Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (K213126) | Smith & Nephew, Inc. | 2022-09-29 |
| OsteoCentric Integrated Hip Fastener System (K210247) | Osteocentric Technologies D.B.A. Osteocentric Trauma | 2021-04-30 |
| CONQUEST FN (K193029) | Smith & Nephew, Inc. | 2020-02-28 |
| THP Hip Fracture Plating System (K173826) | Biomet, Inc. | 2018-02-07 |
| CONQUEST FN (K172785) | Smith & Nephew | 2017-12-22 |
| CONQUEST FN (K152686) | Smith & Nephew | 2016-03-17 |
| TSP HIP FRACTURE PLATING SYSTEM (K140018) | Biomet, Inc. | 2014-04-04 |
| HIPLOC COMPRESSION HIP SCREW (K080685) | Biomet Manufacturing, Inc. | 2008-08-15 |
| INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (K080434) | Smith & Nephew, Inc. | 2008-04-10 |
| SYNTHES (USA) DHS HELIX SYSTEM (K981757) | Synthes (Usa) | 1998-07-17 |
| SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION (K964259) | Synthes (Usa) | 1997-01-09 |
Recalls involving this device
No recalls on record reference this clearance.