Zavation 35-4512SP

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	Number00842166149168 UDI-DI	Date24 Mar 2020Listed	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Withdrawn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: Zavation
Generic Name: Spinal bone screw, non-bioabsorbable
Model / Reference: 35-4512SP

Primary DI / UDI-DI: 00842166149168
510(k) Number: K181244
FDA Product Code: KWQ
GMDN Term: Spinal bone screw, non-bioabsorbable

Device Class: Class II
Regulation Number: 888.3060
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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See all devices from Zavation →

Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

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
Manufacturing Date: No