← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

NXMProsthesis, Eyelid Spacer/Graft, Biologic

For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.

DEVICE CLASS
Class II
REGULATION
21 CFR 886.3130
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
ImplantLife-sustainingGMP-exemptThird-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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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