Conformis Hip System 1080-566

by Conformis, Inc.

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

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850268007606 UDI-DI	Date2 Jun 2020Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00850268007606

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Conformis Hip System
Generic name: Orthopaedic prosthesis implantation positioning instrument, reusable
Model / reference: 1080-566

Primary DI / UDI-DI: 00850268007606
FDA product code: LXH
GMDN term: Orthopaedic prosthesis implantation positioning instrument, reusable

Device class: Class I
Regulation number: 888.4540
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Size: Outer Diameter — 6.5 Millimeter

Other devices from Conformis, Inc.

Conformis Hip System 1080-560

Class I
Actera Hes-034-0002-01

Class II
Identity Imprint Knee Replacement System TCR030063N01 Open recall

Class II
iTotal® Hip Replacement System HAR000S24501

Class II
iTotal® CR iPoly® XE Insert Kit RCR020120013

Class II
iTotal Identity CR RCR020120G01

Class II

See all devices from Conformis, Inc. →

Properties

Sterilise before use
Prescription use
Premarket exempt
Lot / batch number

Other properties (11)

Supplied sterile: No
Single use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Serial number: No
Expiration date: No
Manufacturing date: No