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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
Lumbar interspinous decompression spacer, non-sterile FDA UDI
Device Name
TLIF-LORDOTIC FDA UDI
Model / Reference
1 FDA UDI
Description
TLIF-LORDOTIC FDA UDI

Identifiers

Catalog Number
GT-15-L FDA UDI
Primary DI / UDI-DI
M719GT15L0 FDA UDI
FDA Product Code
ODP FDA UDI
MAX FDA UDI
MQP FDA UDI
GMDN Term
Lumbar interspinous decompression spacer, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
888.3060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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 — 15 Millimeter FDA UDI

Category: Lumbar interspinous decompression spacer, non-sterile

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

Similar devices

Also classified as Lumbar interspinous decompression spacer, non-sterile.

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 81635631-a159-45e1-bcb4-be0641823971 36 fields · synced May 31, 2026