Align Head Alignment Tool, Side Load

by Skeletal Dynamics L.L.C. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841506148960 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Withdrawn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: Align
Generic Name: Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog: Head Alignment Tool, Side Load, ALN-RHG-HATSL

Primary DI / UDI-DI: 00841506148960
FDA Product Code: KWI
GMDN Term: Orthopaedic prosthesis implantation positioning instrument, reusable

Device Class: Class II
Regulation Number: 888.3170
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Prescription Use
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No