Product code HXG
- Device name
- Tamp
- 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 |
|---|---|---|---|
| K841626 | PUNCH | Plastafil, Inc. | 1984-08-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08031497003825 | Mendec® Kypho Set Bilateral 20 mm | TECRES SPA | 2025-12-17 |
| 08031497003818 | Mendec® Kypho Set Bilateral 15 mm | TECRES SPA | 2025-12-17 |
| 08031497003689 | Mendec® Kypho Set Monolateral 10 mm | TECRES SPA | 2025-12-17 |
| 08031497003696 | Mendec® Kypho Set Monolateral 15 mm | TECRES SPA | 2025-12-17 |
| 08031497003702 | Mendec® Kypho Set Monolateral 20 mm | TECRES SPA | 2025-12-17 |
| 08031497003801 | Mendec® Kypho Set Bilateral 10 mm | TECRES SPA | 2025-12-17 |
| 00841732142206 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732166950 | GENERIC Surgical Instruments | CTL Medical Corporation | 2024-11-01 |
| 00192896105591 | Bone Tamp | SONTEC INSTRUMENTS, INC. | 2020-11-18 |
| 00192896105607 | Bone Tamp | SONTEC INSTRUMENTS, INC. | 2020-11-18 |
| 00192896101524 | BONE TAMP | SONTEC INSTRUMENTS, INC. | 2020-05-11 |
| 00192896052130 | BONE TAMP | SONTEC INSTRUMENTS, INC. | 2018-09-24 |
| 00192896082731 | BONE TAMP | SONTEC INSTRUMENTS, INC. | 2018-09-21 |
| 00192896052123 | BONE TAMP | SONTEC INSTRUMENTS, INC. | 2018-09-12 |
| 08057432565791 | SPIDER KOLIBRI | SINTEA PLUSTEK SRL | 2015-10-16 |
| 08057432565784 | SPIDER KOLIBRI | SINTEA PLUSTEK SRL | 2015-10-16 |
| 08057432561342 | SPIDER KOLIBRI | SINTEA PLUSTEK SRL | 2015-10-16 |
| 08057432561335 | SPIDER KOLIBRI | SINTEA PLUSTEK SRL | 2015-10-16 |
| 08057432561328 | SPIDER KOLIBRI | SINTEA PLUSTEK SRL | 2015-10-16 |
| 08057432560000 | SPIDER KOLIBRI | SINTEA PLUSTEK SRL | 2015-10-16 |
| 08057432560628 | SPIDER KOLIBRI | SINTEA PLUSTEK SRL | 2015-10-08 |
| 08057432560635 | SPIDER KOLIBRI | SINTEA PLUSTEK SRL | 2015-10-08 |
| 08057432560642 | SPIDER KOLIBRI | SINTEA PLUSTEK SRL | 2015-10-08 |
| 08057432560659 | SPIDER KOLIBRI | SINTEA PLUSTEK SRL | 2015-10-08 |
| 08057432560666 | SPIDER KOLIBRI | SINTEA PLUSTEK SRL | 2015-10-08 |
| 08057432560673 | SPIDER KOLIBRI | SINTEA PLUSTEK SRL | 2015-10-08 |
| 08033726407084 | SPIDER | SINTEA PLUSTEK SRL | 2015-10-08 |
| 08033726407077 | SPIDER | SINTEA PLUSTEK SRL | 2015-10-08 |
| 08033726407060 | SPIDER | SINTEA PLUSTEK SRL | 2015-10-08 |
| 08033726407053 | SPIDER | SINTEA PLUSTEK SRL | 2015-10-08 |