← Back to catalogue
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
- 8degree TLIF Titanium Silverstone-T FDA UDI
- Model / Reference
- ST83213T2 FDA UDI
- Description
- 8degree TLIF Titanium Silverstone-T FDA UDI
Identifiers
- Primary DI / UDI-DI
- B417ST83213T21 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
- Angle — 8 degree FDA UDIHeight — 13 Millimeter FDA UDIWidth — 10 Millimeter FDA UDILength — 32 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 e70d520b-d019-4ce6-a998-8428c8c06fe8 36 fields · synced May 30, 2026