Product code HWK
- Device name
- Trephine
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- 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 |
|---|---|---|---|
| K851339 | PRECISION HARVEST & INLAY INSTRUMENT SET | Concept, Inc. | 1985-07-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10810128463659 | 9.0mm Can. Full Thickness Drill | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-05-13 |
| 10810128463642 | 8.0mm Can. Full Thickness Drill | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-05-13 |
| 10810128463635 | 7.0mm Can. Full Thickness Drill | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-05-13 |
| 10810128463628 | 4.5mm Can. Full Thickness Drill | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-05-13 |
| 10603295549581 | INHANCE | DEPUY (IRELAND) | 2023-02-28 |
| 00192896038127 | SONTEC-MICHELE TREPHINE | SONTEC INSTRUMENTS, INC. | 2018-09-11 |
| 00192896038110 | SONTEC-MICHELE TREPHINE | SONTEC INSTRUMENTS, INC. | 2018-09-11 |
| 00192896038172 | SONTEC-MICHELE TREPHINE | SONTEC INSTRUMENTS, INC. | 2018-09-11 |
| 00192896038165 | SONTEC-MICHELE TREPHINE | SONTEC INSTRUMENTS, INC. | 2018-09-11 |
| 00192896038158 | SONTEC-MICHELE TREPHINE | SONTEC INSTRUMENTS, INC. | 2018-09-11 |
| 00192896038141 | SONTEC-MICHELE TREPHINE | SONTEC INSTRUMENTS, INC. | 2018-09-11 |
| 00192896038134 | SONTEC-MICHELE TREPHINE | SONTEC INSTRUMENTS, INC. | 2018-09-11 |
| 10381780188025 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780051473 | I.CO.S® | NEWDEAL | 2017-05-26 |
| 10381780051480 | I.CO.S® | NEWDEAL | 2017-05-26 |
| 10810190016524 | 8.0mm Full Thickness Drill | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016517 | 7.5mm Full Thickness Drill | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016500 | 7.0mm Full Thickness Drill | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016494 | 6.5mm Full Thickness Drill | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016487 | 6.0mm Full Thickness Drill | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016470 | 5.5mm Full Thickness Drill | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016463 | 5.0mm Full Thickness Drill | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016456 | 4.5mm Full Thickness Drill | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016289 | 10mm VersiTomic ISI Biosteon Tap | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016272 | 9mm VersiTomic ISI Biosteon Tap | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016265 | 8mm VersiTomic ISI Biosteon Tap | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016258 | 7mm VersiTomic ISI Biosteon Tap | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016241 | 6mm VersiTomic ISI Biosteon Tap | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016036 | Versitomic Sterile Flexible Pin (1 unit - lb2) | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190016029 | Flexible Guide Pin (Stryker ACL Versitomic) | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |