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Zero-P VA

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name
Zero-P VA FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/12MM HEIGHT FDA UDI
Model / Reference
03.647.732 FDA UDI
Description
ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/12MM HEIGHT FDA UDI

Identifiers

Catalog Number
03647732 FDA UDI
Primary DI / UDI-DI
10705034720357 FDA UDI
510(k) Number
K112068 FDA UDI
FDA Product Code
OVE FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Spinal implant trial

Zero-P VA by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K112068 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI 5d4dcc05-7bf6-400e-be54-146cc3820a9d 36 fields · synced May 29, 2026