Skip to content

OsteoMed 811-1008

by Osteomed Corp.

OsteoMed 811-1008 is a Class II device made by Osteomed Corp., listed in FDA GUDID since 25 Jul 2016 (UDI-DI 00845694054850), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00845694054850 UDI-DI Date25 Jul 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
OsteoMed
Generic name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
811-1008
Primary DI / UDI-DI
00845694054850
FDA product code
MAX
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class II
Regulation number
888.3080
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code MAX (Intervertebral fusion device with bone graft, lumbar).

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)