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GSO GS1 Spacer

FDA UDI

Class II (US FDA UDI)

by Unified Spine, Llc

Identity

Trade Name
GSO GS1 Spacer FDA UDI
Generic Name
Orthopaedic bone fixation plate spacer FDA UDI
Device Name
Spacer FDA UDI
Model / Reference
502308 FDA UDI
Description
Spacer FDA UDI

Identifiers

Primary DI / UDI-DI
M9935023081 FDA UDI
FDA Product Code
MQP FDA UDI
GMDN Term
Orthopaedic bone fixation plate spacer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 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: Orthopaedic bone fixation plate spacer

A comprehensive medical device for maintaining a space between an orthopaedic bone fixation plate and the bone to which the plate is fixed, to reduce complications of impaired blood flow in the periosteum.

Similar devices

Also classified as Orthopaedic bone fixation plate spacer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Unified Spine, Llc

Sources (1)

  • FDA UDI edc8f306-b78f-4cd6-9c89-1dd9834b0061 34 fields · synced Jun 29, 2026