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BEAR Implant (Bridge-Enhanced ACL Restoration) 1000

by Miach Orthopaedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860002987804 UDI-DI Date15 Oct 2021ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BEAR Implant (Bridge-Enhanced ACL Restoration)
Generic Name
Joint cartilage biomatrix implant
Model / Reference
1000
Primary DI / UDI-DI
00860002987804
De Novo Number
FDA Product Code
QNI
GMDN Term
Joint cartilage biomatrix implant
Device Class
Class II
Regulation Number
888.3044
GUDID distribution status
In Commercial Distribution

Related devices

Category: Joint cartilage biomatrix implant

Other devices from Miach Orthopaedics, Inc.

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