Identity
- Trade Name
- ACP System Instruments FDA UDI
- Generic Name
- Metal-polymer composite spinal interbody fusion cage FDA UDI
- Device Name
- Ratcheting AO Handle FDA UDI
- Model / Reference
- 20-GC-00013 FDA UDI
- Description
- Ratcheting AO Handle FDA UDI
Identifiers
- Catalog Number
- 20-GC-00013 FDA UDI
- Primary DI / UDI-DI
- M69520GC000130 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Metal-polymer composite spinal interbody fusion cage 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
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
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: Metal-polymer composite spinal interbody fusion cage
ACP System Instruments by Tyber Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metal-polymer composite spinal interbody fusion cage.
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- LUCENT XP ARC — SPINAL ELEMENTS, INC. · Class II
- Shoreline ACS — SeaSpine Orthopedics Corporation · Class II
- MIDLINE II-Ti — Centinel Spine, LLC · Class II
- Latitude-C Cervical Interbody Spacer System — Degen Medical · Class II
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
- Tyber Medical
Sources (1)
- FDA UDI f332689c-0f00-46a6-b5b8-a8e15a1fe6b5 35 fields · synced Jun 1, 2026