Cosy

by SIGNUS Medizintechnik GmbH 302 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 21 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04047844104842 UDI-DI	Date16 Mar 2023Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 21 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog: Shank screw with tulip, cannulated, polyaxial, CA1721-35022

Primary DI / UDI-DI: 04047844104842
510(k) Number: K220658
FDA Product Code: NKG, KWP
GMDN Term: Spinal bone screw, non-bioabsorbable

Device Class: Class II
Regulation Number: 888.3075, 888.3050
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number
Manufacturing Date

Other properties (9)

Sterile: 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