Identity
- Trade Name
- Prodisc C Nova FDA UDI
- Generic Name
- Cervical total intervertebral disc prosthesis, modular FDA UDI
- Device Name
- Prodisc C Nova Large 6mm FDA UDI
- Model / Reference
- PDNL6 FDA UDI
- Description
- Prodisc C Nova Large 6mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843193113566 FDA UDI
- PMA Number
- P070001 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Cervical total intervertebral disc prosthesis, modular
Prodisc C Nova by Centinel Spine, 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
- 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
- ProDisc-C — SYNTHES (U.S.A.) LP · Class III
- PCM — Nuvasive, Inc. · Class III
Cleared under the same submission
P070001 also covers:
- Prodisc C — Centinel Spine, LLC
- Prodisc C — Centinel Spine, LLC
- Prodisc C — Centinel Spine, LLC
- Prodisc C — Centinel Spine, LLC
- Prodisc C — Centinel Spine, LLC
- Prodisc C — Centinel Spine, LLC
- Prodisc C — Centinel Spine, LLC
- Prodisc C — Centinel Spine, LLC
- Prodisc C — Centinel Spine, LLC
- Prodisc C — Centinel Spine, LLC
- Prodisc C Nova — Centinel Spine, LLC
- Prodisc C Nova — Centinel Spine, LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Centinel Spine, LLC
Sources (1)
- FDA UDI 0ea0bbe6-38d3-4e75-9f6e-ce59482b3fc2 34 fields · synced Jun 6, 2026