FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tyber Medical Wedge System
K Number: K150394
·
Decision Jul 28, 2015
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
17
Applicant Total
31
Review Days
160
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Tyber Medical Wedge System
- K Number
- K150394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tyber Medical, LLC
- Date Received
- February 18, 2015
- Decision Date
- July 28, 2015
- Product Code
- PLF
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PLF | Bone Wedge | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PLF), ordered by most recent decision date.
ATLAS Expandable Osteotomy Wedge System
FDA 510(k)
FDA Class 2
·Orthopedic
Osteotomy Wedge System
FDA 510(k)
FDA Class 2
·Orthopedic
Auxano® Wedge Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoSinter® EVANS and COTTON wedges and related accessories
FDA 510(k)
FDA Class 2
·Orthopedic
Trigon PEEK HA Wedges
FDA 510(k)
FDA Class 2
·Orthopedic
Trigon Trigon HA Stand-Alone Wedge Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Tyber Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K261207 | Exalta Proximal Tibia Plating System | Jun 12, 2026 | Substantially Equivalent |
| K260810 | Anteralign LS coverplate | Jun 10, 2026 | Substantially Equivalent |
| K261060 | Navigated LLIF Impactable Tracker | May 29, 2026 | Substantially Equivalent |
| K253042 | Tyber Medical Trauma Screw | Apr 3, 2026 | Substantially Equivalent |
| K252901 | Tyber Medical Trauma Screw | Dec 31, 2025 | Substantially Equivalent |
| K252742 | Navigated Instruments | Oct 28, 2025 | Substantially Equivalent |
| K251361 | Tyber Medical Distal Radius Plating System | Jul 30, 2025 | Substantially Equivalent |
| K242486 | Tyber Medical Anatomical Plating System | Mar 19, 2025 | Substantially Equivalent |
| K241218 | Tyber Medical Anatomical Plating System | May 31, 2024 | Substantially Equivalent |
| K233423 | Tyber Medical Anatomical Plating System Line extension to the Mini-Frag System | Dec 21, 2023 | Substantially Equivalent |