Sigma 1024-53-408

by Depuy (Ireland)

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10603295002598 UDI-DI	Date24 Sep 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Sigma
Generic Name: Unicondylar knee insert
Model / Ref / Catalog: 1024-53-408, 102453408

Primary DI / UDI-DI: 10603295002598
510(k) Number: K070267
K233980
FDA Product Code: NPJ, HRY
GMDN Term: Unicondylar knee insert

Device Class: Class II
Regulation Number: 888.3560, 888.3530
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Conditional

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Properties

Sterile
Single Use
Implantable
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (8)

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