Identity
- Trade Name
- GSO ACP1 Spinal System FDA UDI
- Generic Name
- Orthopaedic bone calliper FDA UDI
- Device Name
- Caliper - Measuring Device FDA UDI
- Model / Reference
- 509716 FDA UDI
- Description
- Caliper - Measuring Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- M9935097160 FDA UDI
- FDA Product Code
- KTZ FDA UDI
- GMDN Term
- Orthopaedic bone calliper FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4150 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
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone calliper
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 bone calliper.
- Invictus — ALPHATEC SPINE, INC. · Class I
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- Novel — ALPHATEC SPINE, INC. · Class I
- Cortera — Xtant Medical Holdings, Inc. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- VerteFIT — Ldr Spine USA · Class I
- Perfix™ MIS — CG MedTech Co., Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Unified Spine, Llc
Sources (1)
- FDA UDI 8da07339-6d3e-4180-94f9-83c406cd5f13 34 fields · synced May 30, 2026