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Apache

FDA UDI

Class II (US FDA UDI)

by Genesys Orthopedics Systems LLC

Identity

Trade Name
Apache FDA UDI
Generic Name
Facet joint prosthesis FDA UDI
Device Name
8mm Large, Convex Apache Anchored Cervical PEEK FDA UDI
Model / Reference
1 FDA UDI
Description
8mm Large, Convex Apache Anchored Cervical PEEK FDA UDI

Identifiers

Catalog Number
GCV-08-LC FDA UDI
Primary DI / UDI-DI
M719GCV08LC0 FDA UDI
FDA Product Code
OVE FDA UDI
GMDN Term
Facet joint prosthesis 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

Yes

FDA UDI

Implantable

Yes

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

Dimensions & Sizes

Size
Height — 8 Millimeter FDA UDI

Category: Facet joint prosthesis

Apache by Genesys Orthopedics Systems LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Facet joint prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genesys Orthopedics Systems LLC

Sources (1)

  • FDA UDI 5b820b7c-f15f-4111-8c6d-dcf2d8cf72b1 36 fields · synced Jun 1, 2026