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Bonalive Orthopedics granules 14120

by Bonalive Oy GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06438132141201 UDI-DIDate31 Aug 2020ListedStatusListed 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  • Withdrawn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 Orthopedics granules
Generic Name
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Model / Ref / Catalog
14120
Primary DI / UDI-DI
06438132141201
510(k) Number
FDA Product Code
MQV
GMDN Term
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Device Class
Class II
Regulation Number
888.3045
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Total Volume — 2.5 Milliliter

Related devices

Category: Bone matrix implant, synthetic, non-antimicrobial

Cleared under the same submission (K191274)

Cleared under the same submission (K231528)

Other devices from Bonalive Oy

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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