Product code KIK
- Device name
- Hook, Bone
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- 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 |
|---|---|---|---|
| K770759 | HOOK HOLLER | Depuy, Inc. | 1977-04-29 |
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| 00847538007930 | Bone Hook - Small | SYMMETRY MEDICAL INC. | 2025-10-20 |
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| 54026704798501 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 14026704798510 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 14026704798503 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 10603295085157 | NA | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |
| 10603295178392 | NA | DEPUY (IRELAND) | 2018-09-24 |
| 10603295178385 | NA | DEPUY (IRELAND) | 2018-09-24 |
| 10603295085140 | NA | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |
| 10886982201478 | NA | SYNTHES (U.S.A.) LP | 2017-02-20 |
| 10886982201461 | NA | SYNTHES (U.S.A.) LP | 2017-02-20 |
| 10886982201423 | NA | Synthes GmbH | 2016-12-31 |
| 10886982201416 | NA | Synthes GmbH | 2016-12-31 |
| 10886982201409 | NA | Synthes GmbH | 2016-12-31 |
| 10886982192974 | NA | Synthes GmbH | 2016-12-31 |
| 10886982192967 | NA | Synthes GmbH | 2016-12-31 |
| 10886982192943 | NA | Synthes GmbH | 2016-12-31 |
| 10886982192912 | NA | Synthes GmbH | 2016-12-31 |
| 10886982070791 | NA | Synthes GmbH | 2016-12-31 |
| 10886982070784 | NA | Synthes GmbH | 2016-12-31 |
| 10886982005434 | NA | SYNTHES (U.S.A.) LP | 2016-12-31 |