← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

PLF — Bone Wedge

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

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3030
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K252733MiRus, LLC · 510k2026-02-19
K252254Sinaptic Surgical · 510k2025-10-17
K251791Auxano Medical, LLC · 510k2025-09-25
K240461Ames Medical Prosthetic Solutions, S.A.U. · 510k2024-12-06
K243231Nvision Biomedical Technologies · 510k2024-11-08

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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