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FDA PRODUCT CODE · CLASS II

PBF — Orthopaedic Surgical Planning And Instrument Guides

As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3030
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
10
510(K)/PMA CLEARANCES
510k: 10
0
RECALL ENTRIES

Recent clearances

K252064Medcad · 510k2026-03-27
K2507113D Systems, Inc. · 510k2025-12-05
K242603Medacta International S.A. · 510k2025-11-19
K251709Medcad · 510k2025-11-04
K250394Bodycad Laboratories, Inc. · 510k2025-10-21
K250767Newclip Technics · 510k2025-10-01
K250921Blue Belt Technologies, Inc. · 510k2025-06-25
K241811Medcad · 510k2025-03-13

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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