← Back to catalogue

Genesys Spine Apache® Interbody Fusion System

FDA UDI

Class II (US FDA UDI)

by Genesys Orthopedics Systems LLC

Identity

Trade Name
Genesys Spine Apache® Interbody Fusion System FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
10mm X 32mm 3DP Parallel TPLIF Ingot Trial FDA UDI
Model / Reference
1 FDA UDI
Description
10mm X 32mm 3DP Parallel TPLIF Ingot Trial FDA UDI

Identifiers

Catalog Number
GP732-10 FDA UDI
Primary DI / UDI-DI
M719GP732100 FDA UDI
510(k) Number
K153123 FDA UDI
FDA Product Code
MAX 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

Dimensions & Sizes

Size
Length — 32 Millimeter FDA UDI
Width — 10 Millimeter FDA UDI

Category: Spinal implant trial

Genesys Spine Apache® Interbody Fusion System by Genesys Orthopedics Systems LLC — 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

K153123 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Genesys Orthopedics Systems LLC

Sources (1)

  • FDA UDI 36c8ef99-7f65-4fdd-9424-8a084447e2bb 37 fields · synced Jun 1, 2026