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FDA PRODUCT CODE · CLASS II

QFP — Intraoperative Orthopedic Strain Sensor

A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision-making.

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3090
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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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