Tyber Medical Wedge System
FDA 510(k) K171327 · Tyber Medical, LLC
510(k) numberK171327
Submission
- Device name
- Tyber Medical Wedge System
- Applicant
- Tyber Medical, LLC
Bethlehem, PA, US - Received
- May 5, 2017
- Decision date
- May 16, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLF – Bone Wedge
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
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| K253042 | Tyber Medical Trauma ScrewHWC · Traditional | 04/03/2026SE |
| K252901 | Tyber Medical Trauma ScrewHWC · Traditional | 12/31/2025SE |
| K252742 | Navigated InstrumentsOLO · Traditional | 10/28/2025SE |
| K251361 | Tyber Medical Distal Radius Plating SystemHRS · Traditional | 07/30/2025SE |
| K242486 | Tyber Medical Anatomical Plating SystemHRS · Traditional | 03/19/2025SE |
| K241218 | Tyber Medical Anatomical Plating SystemHRS · Special | 05/31/2024SE |
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Questions and answers
When was Tyber Medical Wedge System cleared by the FDA?
Tyber Medical Wedge System (K171327) received a 510(k) decision of Substantially Equivalent on May 16, 2017, 11 days after the submission was received.
What is the product code of K171327?
The FDA product code is PLF – Bone Wedge, a Class II (moderate risk) device regulated under 21 CFR 888.3030.