Identity
- Trade Name
- M6-C FDA UDI
- Generic Name
- Cervical total intervertebral disc prosthesis, modular FDA UDI
- Device Name
- M6-C Implant Case Kit – Ancillary FDA UDI
- Model / Reference
- FG 0169 FDA UDI
- Description
- M6-C Implant Case Kit – Ancillary FDA UDI
Identifiers
- Catalog Number
- ICC-0000-10 FDA UDI
- Primary DI / UDI-DI
- 00812388031312 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
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.
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- 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 5056ddee-33cc-434e-9f2f-8c869971b74f 35 fields · synced Jun 8, 2026