Product code HTT
- Device name
- Burr, Orthopedic
- 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 |
|---|---|---|---|
| K862529 | HALL STERILE BUR | Hall Surgical, Division of Zimmer, Inc. | 1986-07-15 |
| K821695 | MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER | Micro-Aire Surgical Instruments, Inc. | 1982-07-20 |
| K802598 | CARBIDE CUTTING INSTRUMENT/INTRAARTICU | The Anspach Effort, Inc. | 1980-11-19 |
| K760236 | BUR, SURGICAL CARBIDE | Cutter Laboratories, Inc. | 1976-07-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07899258658285 | Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-15 |
| 07899258658278 | Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-15 |
| 07899258658261 | Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-15 |
| 07899258658254 | Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-15 |
| 07899258658230 | Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-15 |
| 07899258658247 | Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-15 |
| 07899258638874 | Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-11 |
| 07899258638867 | Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-11 |
| 07899258638928 | Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-11 |
| 07899258638911 | Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-11 |
| 07899258638898 | Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-11 |
| 07899258638881 | Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-11 |
| 08809288930175 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930168 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930151 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930144 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930137 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930120 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930113 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930106 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930090 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930083 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930076 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930069 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930052 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930045 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930038 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930021 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930014 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |
| 08809288930007 | IMEDICOM HIGH SPEED BLADE | IMEDICOM CO., LTD. | 2018-07-13 |