Product code KDG
- Device name
- Chisel (Osteotome)
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4820
- 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 |
|---|---|---|---|
| K952678 | STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT | Avail-Southwest Division | 1995-07-10 |
| K952200 | OMNI-JUG | Waterstone Medical, Inc. | 1995-06-29 |
| K894785 | SURGICAL CHISEL/OSTEOTOME | Fdt Precision Machine Co., Inc. | 1989-08-18 |
| K891471 | SIL-MED WASTE FLUID DUMP BAG | Sil-Med Corp. | 1989-08-15 |
| K872947 | POREX QUALITY PLASTIC SURGERY INSTRUMENTS | Porex Medical | 1987-08-21 |
| K872092 | OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 | Military Engineering, Inc. | 1987-06-23 |
| K842824 | CHERMEL BONE CHISELS | Cher Mel Corp. | 1984-08-02 |
| K772373 | ANDERSON-NEIVERT OSTEOTOME | Edward Weck, Inc. | 1978-03-09 |
| K772374 | SILVER OSTEOTOME | Edward Weck, Inc. | 1978-03-09 |
| K772376 | NEIVERT OSTEOTOME | Edward Weck, Inc. | 1978-03-09 |
| K780135 | CEMENT EXTRACTION INSTRUMENT SET | Orthopedic Equipment Co., Inc. | 1978-01-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10840199527417 | Osteotome | KOROS U.S.A., INC. | 2024-12-31 |
| 10840199527400 | Osteotome | KOROS U.S.A., INC. | 2024-12-31 |
| 10840199527394 | Osteotome | KOROS U.S.A., INC. | 2024-12-31 |
| 10840199511430 | Chisel | KOROS U.S.A., INC. | 2024-12-31 |
| 10840199511423 | Chisel | KOROS U.S.A., INC. | 2024-12-31 |
| 10840199523457 | Osteotome | KOROS U.S.A., INC. | 2024-01-31 |
| 10840199523440 | Osteotome | KOROS U.S.A., INC. | 2024-01-31 |
| 10840199522986 | Osteotome | KOROS U.S.A., INC. | 2024-01-31 |
| 10840199522283 | Osteotome | KOROS U.S.A., INC. | 2024-01-31 |
| 10840199522276 | Osteotome | KOROS U.S.A., INC. | 2024-01-31 |
| 10840199522269 | Osteotome | KOROS U.S.A., INC. | 2024-01-31 |
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| 07898506854127 | Quinelato | Schobell Industrial Ltda | 2022-12-08 |