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, 30mm x 38mm, 19mm FDA UDI
- Model / Reference
- SPO-3038-1519 FDA UDI
- Description
- Bi-Convex 15° Lordotic, 30mm x 38mm, 19mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B030SPO303815190 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 — 38 Millimeter FDA UDIHeight — 19 Millimeter FDA UDIDepth — 30 Millimeter FDA UDI
Category: Metallic spinal fusion cage, non-sterile
The SPIRA-O Open Matrix OLIF medical device is a non-sterile, hollow and/or porous cylindrical device used for spinal fusion. It is designed to provide mechanical stability and sufficient space for therapeutic bone fusion to occur.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Camber Spine Technologies
Sources (1)
- FDA UDI b5e5d623-f7ae-431a-a2c4-253ddbc59277 36 fields · synced Jul 9, 2026