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Silverstone Titanium Interbody Fusion System
FDA UDIClass II (US FDA UDI)
by Altus Spine
Identity
- Trade Name
- Silverstone Titanium Interbody Fusion System FDA UDI
- Generic Name
- Metallic spinal fusion cage, non-sterile FDA UDI
- Device Name
- 22L PLIF Titanium Silverstone-P FDA UDI
- Model / Reference
- SP221013T2 FDA UDI
- Description
- 22L PLIF Titanium Silverstone-P FDA UDI
Identifiers
- Primary DI / UDI-DI
- B417SP221013T21 FDA UDI
- 510(k) Number
- K171329 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 — 10 Millimeter FDA UDILength — 22 Millimeter FDA UDIHeight — 13 Millimeter FDA UDI
Category: Metallic spinal fusion cage, non-sterile
Silverstone Titanium Interbody Fusion System by Altus Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic spinal fusion cage, non-sterile.
- 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
- SPIRA™-C Open Matrix Cervical Interbody — CAMBER SPINE TECHNOLOGIES · Class II
- IVA Cage Ti — Dio Medical Co., Ltd. · Class II
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC · Class II
- IVA Cage Ti — Dio Medical Co., Ltd. · Class II
Cleared under the same submission
K171329 also covers:
- Silverstone Titanium Interbody Fusion System — Altus Spine
- Silverstone Titanium Interbody Fusion System — Altus Spine
- Silverstone Titanium Interbody Fusion System — Altus Spine
- Silverstone Titanium Interbody Fusion System — Altus Spine
- Silverstone Titanium Interbody Fusion System — Altus Spine
- Silverstone Titanium Interbody Fusion System — Altus Spine
- Silverstone Titanium Interbody Fusion System — Altus Spine
- Silverstone Titanium Interbody Fusion System — Altus Spine
- Silverstone Titanium Interbody Fusion System — Altus Spine
- Silverstone Titanium Interbody Fusion System — Altus Spine
- Silverstone Titanium Interbody Fusion System — Altus Spine
- Silverstone Titanium Interbody Fusion System — Altus Spine
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
- Altus Spine
Sources (1)
- FDA UDI 39781d96-8ced-4c5d-88d4-661c0336ae84 36 fields · synced Jun 8, 2026