← Back to catalogue

GSO ACP1 Spinal System

FDA UDI

Class I (US FDA UDI)

by Unified Spine, Llc

Identity

Trade Name
GSO ACP1 Spinal System FDA UDI
Generic Name
Orthopaedic fixation plate bending insert, single-use FDA UDI
Device Name
Single Use temporary Fixation Pin FDA UDI
Model / Reference
509735 FDA UDI
Description
Single Use temporary Fixation Pin FDA UDI

Identifiers

Primary DI / UDI-DI
M9935097350 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic fixation plate bending insert, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

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: Orthopaedic fixation plate bending insert, single-use

GSO ACP1 Spinal System by Unified Spine, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic fixation plate bending insert, single-use.

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
Unified Spine, Llc

Sources (1)

  • FDA UDI 5a2da7ab-7bdf-4869-a8c3-1a1bddece933 34 fields · synced May 31, 2026