Protean CMC Osteotomy K-Wire Placement Guide

by Skeletal Dynamics L.L.C. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841506145495 UDI-DI	Date1 Dec 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name: Protean
Generic Name: Surgical drill guide, reusable
Model / Ref / Catalog: CMC Osteotomy K-Wire Placement Guide, PRT-KWGD-CMC

Primary DI / UDI-DI: 00841506145495
FDA Product Code: LXH
GMDN Term: Surgical drill guide, reusable

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

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Prescription Use
Premarket Exempt
Lot / Batch Number

Other properties (11)

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