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Software For Diagnosis/Treatment

FDA product code OSN · 3 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
2018-08-13 – 2026-02-26

Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions

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