Identity
- Trade Name
- M6-C FDA UDI
- Generic Name
- Cervical total intervertebral disc prosthesis, modular FDA UDI
- Device Name
- Artificial Cervical Disc, 7L (7mm H x 17mm W x 14mm D) FDA UDI
- Model / Reference
- 7L FDA UDI
- Description
- Artificial Cervical Disc, 7L (7mm H x 17mm W x 14mm D) FDA UDI
Identifiers
- Catalog Number
- CDL-727 (FG 0005-06) FDA UDI
- Primary DI / UDI-DI
- 00812388030070 FDA UDI
- PMA Number
- P170036 FDA UDI
- FDA Product Code
- MJO FDA UDI
- GMDN Term
- Cervical total intervertebral disc prosthesis, modular FDA UDI
Classification
- Device Class
- Class III 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Cervical total intervertebral disc prosthesis, modular
M6-C by Spinal Kinetics, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cervical total intervertebral disc prosthesis, modular.
- Simplify — Nuvasive, Inc. · Class III
- SECURE-C — GLOBUS MEDICAL, INC. · Class III
- Prodisc C Vivo — Centinel Spine, LLC · Class III
- Prodisc C Vivo — Centinel Spine, LLC · Class III
- SECURE-C — GLOBUS MEDICAL, INC. · Class III
- Simplify® Cervical Artificial Disc — Nuvasive, Inc. · Class III
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- Mobi-C® Plug & Fit US — Ldr Spine USA · Class III
Cleared under the same submission
P170036 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Spinal Kinetics, LLC
Sources (1)
- FDA UDI 5789e2ac-400a-4eab-b12c-49268107dbdc 35 fields · synced May 30, 2026