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Orthinox 6364-2-030

by Howmedica Osteonics Corp.

Orthinox 6364-2-030 is a Class II device made by Howmedica Osteonics Corp., listed in FDA GUDID since 24 Sep 2015 (UDI-DI 04546540273284), 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

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04546540273284 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: 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  • Withdrawn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
Orthinox
Generic name
Metallic femoral head prosthesis
Model / Ref / Catalog
6364-2-030
Primary DI / UDI-DI
04546540273284
FDA product code
KWZ, KWL, LWJ, MEH, KWY, JDI, LZO, MBL, MAY, LPH
GMDN term
Metallic femoral head prosthesis
Device class
Class II
Regulation number
888.3310, 888.3360, 888.3353, 888.3390, 888.3350, 888.3358
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 30.0 Millimeter

Related devices

Category: Metallic femoral head prosthesis

Similar devices in this category

Other devices filed under Metallic femoral head prosthesis.

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)