Product code HWN
- Device name
- Instrument, Compression
- 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 |
|---|---|---|---|
| K854241 | AOT EXTERNAL COMPRESS DEVICE | Advanced Ortho-Technology, Inc. | 1986-03-03 |
| K792253 | ARICULATED TENSION DEVICE SYNTHES TEN | Synthes (Usa) | 1979-12-05 |
| K770349 | RIGID TEACHING ATTACHMENT | Richard Wolf Medical Instruments Corp. | 1977-03-07 |
| K760970 | FLORIO CPC BAND | Richard'S Medical Equip., Inc. | 1976-11-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10886982357342 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357830 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357823 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357489 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357472 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357465 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357458 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357441 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357434 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357410 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357403 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357397 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357380 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357373 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357366 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357359 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357335 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357427 | VOLT | Synthes GmbH | 2026-09-25 |
| 00850083430009 | SOLOFIX Provisional Fixation System | AXIA ORTHOPEDICS, INC. | 2026-08-17 |
| 00850083430092 | SOLOFIX Provisional Fixation System | AXIA ORTHOPEDICS, INC. | 2026-08-17 |
| 00850083430078 | SOLOFIX Provisional Fixation System | AXIA ORTHOPEDICS, INC. | 2026-08-17 |
| 00850083430047 | SOLOFIX Provisional Fixation System | AXIA ORTHOPEDICS, INC. | 2026-08-17 |
| 00810111228374 | Positioner / Compressor | Treace Medical Concepts, Inc. | 2026-07-17 |
| 00810111228381 | Positioner / Compressor | Treace Medical Concepts, Inc. | 2026-07-17 |
| 00841732164246 | GENERIC Surgical Instruments | CTL Medical Corporation | 2023-09-15 |
| 00841732164185 | GENERIC Surgical Instruments | CTL Medical Corporation | 2023-09-14 |
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| 07640178982819 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640151081997 | ROMEO 2 INSTRUMENTATION | SpineArt SA | 2018-12-19 |
| 07640151084301 | ROMEO 2 INSTRUMENTATION | SpineArt SA | 2018-12-19 |