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FDA PRODUCT CODE · CLASS II

QHG — Defect Measurement Tool

Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in terms of geometry, surgical technique, and use of the device.

DEVICE CLASS
Class II
REGULATION
21 CFR 888.4510
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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