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Bone Wedge

FDA product code PLF · 16 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3030
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-04-03 – 2026-02-19

Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.

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