← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3045
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
ImplantLife-sustainingGMP-exemptThird-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K242799Lifenet Health · 510k2024-11-21

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA 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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