Identity
- Trade Name
- CAPSTONE CONTROL™ Spinal System FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- SPACER 3991422 CAPSTONE IR 0 DEG 14X22 FDA UDI
- Model / Reference
- 3991422 FDA UDI
- Description
- SPACER 3991422 CAPSTONE IR 0 DEG 14X22 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169055452 FDA UDI
- 510(k) Number
- K120368 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Polymeric 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
Yes
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
Dimensions & Sizes
- Size
- Angle — 0.0 degree FDA UDIOuter Diameter — 14.0 Millimeter FDA UDILength — 22.0 Millimeter FDA UDI
Category: Polymeric spinal interbody fusion cage
CAPSTONE CONTROL™ Spinal System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric spinal interbody fusion cage.
- L-Box® — Innovasis, Inc. · Class II
- CoRoent — Nuvasive, Inc. · Class II
- Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- S-LIFT® — SPINEFRONTIER, INC. · Class II
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
- Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Cleared under the same submission
K120368 also covers:
- CAPSTONE CONTROL™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE CONTROL™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE CONTROL™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE CONTROL™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE CONTROL™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE CONTROL™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE CONTROL™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE CONTROL™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE CONTROL™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE CONTROL™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE CONTROL™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE CONTROL™ 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 b5206643-48e1-4c4a-93d5-5d2d58097e0e 36 fields · synced May 31, 2026