Zavation VCF-DDBAK

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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	Number00842166184923 UDI-DI	Date28 Jul 2020Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Zavation
Generic Name: Balloon kyphoplasty kit
Model / Reference: VCF-DDBAK

Primary DI / UDI-DI: 00842166184923
FDA Product Code: NDN, HRX, GAA
GMDN Term: Balloon kyphoplasty kit

Device Class: Class II
Regulation Number: 888.3027, 888.1100, 878.4800
GUDID distribution status: In Commercial Distribution

Sterilization Method: Ethylene Oxide

Other devices from Zavation

Zavation Screw 1011-O-105060-C-C

Class II
Zavation Screw 1011-O-105065-C-C

Class II
Zavation Screw 1011-O-105070-C-C

Class II
Zavation Screw 1011-O-105075-C-C

Class II
Zavation Screw 1011-O-105080-C-C

Class II
Zavation Screw 1011-O-105085-C-C

Class II

See all devices from Zavation →

Properties

Sterile
Single Use
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (9)

Implantable: No
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