Stratum Ankle SALS5020NS

by Medartis Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 22 Oct 2026

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	Number00810082890983 UDI-DI	Date26 May 2023Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Stratum Ankle
Generic Name: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Model / Reference: SALS5020NS

Primary DI / UDI-DI: 00810082890983
510(k) Number: K212640
FDA Product Code: HWC
GMDN Term: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Device Class: Class II
Regulation Number: 888.3040
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Single Use
Lot / Batch Number
Manufacturing Date

Other properties (11)

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