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Orthopaedic Surgical Planning And Instrument Guides

FDA product code PBF · 26 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3030
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2012-07-20 – 2026-03-27

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.

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