Identity
- Trade Name
- CAPSTONE® Spinal System FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- CAGE X1204273 CAPSTONE 12 X 22 X 8 WIDE FDA UDI
- Model / Reference
- X1204273 FDA UDI
- Description
- CAGE X1204273 CAPSTONE 12 X 22 X 8 WIDE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885074372730 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage 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
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
No
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: Metallic spinal interbody fusion cage
CAPSTONE® Spinal System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metallic spinal interbody fusion cage.
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Cleared under the same submission
K041556 also covers:
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
K121760 also covers:
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI c81619f5-8435-48cb-910e-982086d7bdb9 36 fields · synced Jun 8, 2026