510(k) K150394
- Device
- Tyber Medical Wedge System
- Applicant
- TYBER MEDICAL LLC
- 510(k) number
- K150394
- Product code
- PLF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-07-28
- Date received
- 2015-02-18
- Regulation
- 888.3030
- Classification name
- Bone Wedge
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFF TYBER
- Address
- 89 Headquarters Plz. N. #1464 Morristown NJ US 07960 07960
FDA Registration Numbers#
- 3014273501
- 3016851379
- 2245304
- 1220246
- 3017597868
- 3009923578
- 3014004349
- 1423662
- 3009540749
- 3015231789
- 3030271054
- 3003477135
- 1319660
- 3011301313
- 3017980495
- 3015806723
- 3020704423
- 1054811
- 3019269298
- 3010400367
- 1526534
- 3003236702
- 3012966183
- 1720929
- 3027339877
- 3005032068
- 2027062
- 3010123256
- 3014655115
- 3010331645
- 3009973336
- 3009826895
- 3014833750
- 1833506
- 1935627
- 3036718423
- 3013194153
- 3009513193
- 3008650117
Source Documents#
Other 510(k) Records For Product Code PLF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252733 | ATLAS™ Expandable Osteotomy Wedge System | MiRus, LLC | 2026-02-19 |
| K252254 | Osteotomy Wedge System | Sinaptic Surgical | 2025-10-17 |
| K251791 | Auxano® Wedge Fixation System | Auxano Medical, LLC | 2025-09-25 |
| K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | 2024-12-06 |
| K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024-11-08 |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies | 2024-01-26 |
| K231496 | TITAN 3-D Wedge System | Paragon 28, Inc. | 2023-08-22 |
| K223226 | Trigon™ HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022-12-01 |
| K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022-02-23 |
| K201314 | Restor3d Utility Wedge | Restor3D, Inc. | 2021-06-17 |
| K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020-12-21 |
| K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020-02-25 |
| K192645 | Trigon™ Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2019-12-23 |
| K191047 | ADI TiDAL Osteotomy Wedge | Additive Device, Inc. (Adi) D/B/A Restor3D | 2019-11-05 |
| K171327 | Tyber Medical Wedge System | Tyber Medical, LLC | 2017-05-16 |
Legacy Summary#
summary
FDA Review#
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