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Bonalive Maxillofacial 17120

by Bonalive Oy GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06438132171208 UDI-DIDate1 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Bonalive Maxillofacial
Generic Name
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Model / Ref / Catalog
17120
Primary DI / UDI-DI
06438132171208
510(k) Number
FDA Product Code
LYC
GMDN Term
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Device Class
Class II
Regulation Number
872.3930
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Total Volume — 2.5 Milliliter

Related devices

Cleared under the same submission (K253883)

Other devices from Bonalive Oy

See all devices from Bonalive Oy →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No