Identity
- Trade Name
- PEEK PREVAIL™ Cervical Interbody Device FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- SPACER 9010000039 PRV PK 16X12X9 FDA UDI
- Model / Reference
- 9010000039 FDA UDI
- Description
- SPACER 9010000039 PRV PK 16X12X9 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994646019 FDA UDI
- 510(k) Number
- K094042 FDA UDI
- FDA Product Code
- ODP 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
Category: Polymeric spinal interbody fusion cage
PEEK PREVAIL™ Cervical Interbody Device 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
K094042 also covers:
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- PEEK PREVAIL™ Cervical Interbody Device — MEDTRONIC SOFAMOR DANEK, INC.
- PEEK PREVAIL™ Cervical Interbody Device — MEDTRONIC SOFAMOR DANEK, INC.
- PEEK PREVAIL™ Cervical Interbody Device — MEDTRONIC SOFAMOR DANEK, INC.
- PEEK PREVAIL™ Cervical Interbody Device — MEDTRONIC SOFAMOR DANEK, INC.
- PEEK PREVAIL™ Cervical Interbody Device — MEDTRONIC SOFAMOR DANEK, INC.
- PEEK PREVAIL™ Cervical Interbody Device — MEDTRONIC SOFAMOR DANEK, INC.
- PEEK PREVAIL™ Cervical Interbody Device — 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 0c6f8508-f8c3-43a8-be9b-2754014706e6 36 fields · synced May 30, 2026