OsteoMed 218-3085-SP

by Osteomed Corp.

OsteoMed 218-3085-SP is a Class II device made by Osteomed Corp., listed in FDA GUDID since 7 Apr 2015 (UDI-DI 00845694045049), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00845694045049 UDI-DI	Date7 Apr 2015Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00845694045049

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: OsteoMed
Generic name: Cranioplasty plate, alterable
Model / Ref / Catalog: 218-3085-SP

Primary DI / UDI-DI: 00845694045049
FDA product code: PBJ
GMDN term: Cranioplasty plate, alterable

Device class: Class II
Regulation number: 882.5330
GUDID distribution status: In Commercial Distribution

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date

Other properties (9, all answered No)