Skip to content

Bioscrew C8022

by Conmed Corporation

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20845854013608 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bioscrew
Generic Name
Bioabsorbable orthopaedic bone screw
Model / Ref / Catalog
C8022
Primary DI / UDI-DI
20845854013608
510(k) Number
FDA Product Code
HWC
GMDN Term
Bioabsorbable orthopaedic bone screw
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Safe
Size
Length — 25 Millimeter
Outer Diameter — 10 Millimeter

Related devices

Cleared under the same submission (K973758)

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