Product code JDO
- Device name
- Device, Fixation, Proximal Femoral, Implant
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230764 | OsteoCentric Integrated Hip Fastener System | OsteoCentric Technologies | 2023-04-18 |
| K213126 | 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 | Smith & Nephew, Inc. | 2022-09-29 |
| K210247 | OsteoCentric Integrated Hip Fastener System | Osteocentric Technologies D.B.A. Osteocentric Trauma | 2021-04-30 |
| K193029 | CONQUEST FN | Smith & Nephew, Inc. | 2020-02-28 |
| K173826 | THP Hip Fracture Plating System | Biomet, Inc. | 2018-02-07 |
| K172785 | CONQUEST FN | Smith & Nephew | 2017-12-22 |
| K152686 | CONQUEST FN | Smith & Nephew | 2016-03-17 |
| K140018 | TSP HIP FRACTURE PLATING SYSTEM | Biomet, Inc. | 2014-04-04 |
| K080685 | HIPLOC COMPRESSION HIP SCREW | Biomet Manufacturing, Inc. | 2008-08-15 |
| K080434 | INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW | Smith & Nephew, Inc. | 2008-04-10 |
| K983814 | GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM | Efratgo, Ltd. HI Tech Bio-Surgical | 1999-01-14 |
| K981757 | SYNTHES (USA) DHS HELIX SYSTEM | Synthes (Usa) | 1998-07-17 |
| K964259 | SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION | Synthes (Usa) | 1997-01-09 |
| K962644 | VIGOR COMPRESSION HIP SCREW SYSTEM | Deutschland Surgical, Inc. | 1996-09-06 |
| K953607 | TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS) | Synthes (Usa) | 1996-03-08 |
| K951904 | SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] | Synthes (Usa) | 1995-07-17 |
| K934161 | PROFORM HIP SYSTEM | Stelkast Company | 1994-03-10 |
| K934162 | PROFORM HA HIP SYSTEM | Stelkast Company | 1994-03-09 |
| K923613 | SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT | Synthes (Usa) | 1993-06-22 |
| K831076 | COMPRESSION SYSTEM | Kirschner Medical Corp. | 1983-04-28 |
| K810258 | PROXIMAL FERMORAL HIP REPLACEMENT | Biomet, Inc. | 1981-03-05 |
| K781389 | BIOMET CONCENTRIC HEX SCREW | Biomet, Inc. | 1978-08-21 |
| K780187 | NAIL, MASSIE II | Howmedica Corp. | 1978-03-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10886982175144 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175304 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175298 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175281 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175274 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175267 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175250 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175243 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175236 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175229 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175212 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175182 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175175 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175168 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175151 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982174994 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175137 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175120 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175113 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175106 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175090 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175083 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175076 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175069 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175052 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175045 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175038 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175021 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175014 | DHS | Synthes GmbH | 2015-09-14 |
| 10886982175007 | DHS | Synthes GmbH | 2015-09-14 |