Product code GFG
- Device name
- Bit, Surgical
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10080196393152 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-01-29 |
| 10810190018917 | VersiTomic® ACL Flexible Reamer System Flexible Guide Pin | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2024-01-08 |
| 08800066100056 | SST Pro Tip | SeoulinMedicare Co.,Ltd. | 2022-05-27 |
| 08800066100063 | SST Pro Tip | SeoulinMedicare Co.,Ltd. | 2022-05-27 |
| 08800066100070 | SST Pro Tip | SeoulinMedicare Co.,Ltd. | 2022-05-27 |
| 08800066100087 | SST Pro Tip | SeoulinMedicare Co.,Ltd. | 2022-05-27 |
| 08800066100094 | SST Pro Tip | SeoulinMedicare Co.,Ltd. | 2022-05-27 |
| 08800066100100 | SST Pro Tip | SeoulinMedicare Co.,Ltd. | 2022-05-27 |
| 10705034731841 | NA | Synthes GmbH | 2019-08-10 |
| 07613153089025 | NA | STRYKER CORPORATION | 2018-09-23 |
| 07613153089018 | NA | STRYKER CORPORATION | 2018-09-23 |
| 07613153089124 | NA | STRYKER CORPORATION | 2018-09-23 |
| 07613153089070 | NA | STRYKER CORPORATION | 2018-09-23 |
| M684200710071 | SUPERPATH® | Microport Orthopedics Inc. | 2018-09-04 |
| M684161090201 | ORTHOLOC® | Microport Orthopedics Inc. | 2018-08-31 |
| 10705034731858 | NA | SYNTHES (U.S.A.) LP | 2018-07-19 |
| 10705034731889 | NA | SYNTHES (U.S.A.) LP | 2018-07-19 |
| 10705034731872 | NA | SYNTHES (U.S.A.) LP | 2018-07-19 |
| 10705034731865 | NA | SYNTHES (U.S.A.) LP | 2018-07-19 |
| 10705034731834 | NA | SYNTHES (U.S.A.) LP | 2018-07-19 |
| 10705034731827 | NA | SYNTHES (U.S.A.) LP | 2018-07-19 |
| 10705034731582 | NA | SYNTHES (U.S.A.) LP | 2018-07-19 |
| M684161090081 | ORTHOLOC® | Microport Orthopedics Inc. | 2017-04-13 |
| M684186101411 | ADVANTIM® | Microport Orthopedics Inc. | 2017-04-13 |
| M6842271DR04001 | Axiom | Microport Orthopedics Inc. | 2017-03-09 |
| M6842271DR05001 | Axiom | Microport Orthopedics Inc. | 2017-03-09 |
| M6842271DR08001 | Axiom | Microport Orthopedics Inc. | 2017-03-09 |
| M684200101811 | MicroPort | Microport Orthopedics Inc. | 2017-03-07 |
| M684200101821 | MicroPort | Microport Orthopedics Inc. | 2017-03-07 |
| M684200101841 | MicroPort | Microport Orthopedics Inc. | 2017-03-07 |