Identity
- Trade Name
- SPIRA-O Open Matrix OLIF FDA UDI
- Generic Name
- Metallic spinal fusion cage, non-sterile FDA UDI
- Device Name
- Bi-Convex 15° Lordotic, 26mm x 32mm, 11mm FDA UDI
- Model / Reference
- SPO-2632-1511 FDA UDI
- Description
- Bi-Convex 15° Lordotic, 26mm x 32mm, 11mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B030SPO263215110 FDA UDI
- 510(k) Number
- K162986 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metallic spinal fusion cage, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 32 Millimeter FDA UDIHeight — 11 Millimeter FDA UDIDepth — 26 Millimeter FDA UDI
Category: Metallic spinal fusion cage, non-sterile
SPIRA-O Open Matrix OLIF by Camber Spine Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic spinal fusion cage, non-sterile.
- Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
- Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
- TraXis® — ZIMMER SPINE, INC. · Class II
- PLIF Cage — Eisertech, LLC · Class II
- IVA Cage Ti — Dio Medical Co., Ltd. · Class II
- Copperhead — EMINENT SPINE LLC · Class II
- IVA Cage Ti — Dio Medical Co., Ltd. · Class II
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC · Class II
Cleared under the same submission
K162986 also covers:
- SPIRA-O Open Matrix OLIF — CAMBER SPINE TECHNOLOGIES
- SPIRA-O Open Matrix OLIF — CAMBER SPINE TECHNOLOGIES
- SPIRA-O Open Matrix OLIF — CAMBER SPINE TECHNOLOGIES
- SPIRA-O Open Matrix OLIF — CAMBER SPINE TECHNOLOGIES
- SPIRA-O Open Matrix OLIF — CAMBER SPINE TECHNOLOGIES
- SPIRA-O Open Matrix OLIF — CAMBER SPINE TECHNOLOGIES
- SPIRA-O Open Matrix OLIF — CAMBER SPINE TECHNOLOGIES
- SPIRA-O Open Matrix OLIF — CAMBER SPINE TECHNOLOGIES
- SPIRA-O Open Matrix OLIF — CAMBER SPINE TECHNOLOGIES
- SPIRA-O Open Matrix OLIF — CAMBER SPINE TECHNOLOGIES
- SPIRA-O Open Matrix OLIF — CAMBER SPINE TECHNOLOGIES
- SPIRA-O Open Matrix OLIF — CAMBER SPINE TECHNOLOGIES
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 II | Pending data |
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Manufacturer
- Manufacturer
- Camber Spine Technologies
Sources (1)
- FDA UDI 40e6de75-6362-439b-8aa6-5c48e044ade5 36 fields · synced May 30, 2026