Identity
- Trade Name
- PCM FDA UDI
- Generic Name
- Cervical total intervertebral disc prosthesis, modular FDA UDI
- Device Name
- Artificial Vertebral Disc, 7.2 mm Large FDA UDI
- Model / Reference
- 7680472 FDA UDI
- Description
- Artificial Vertebral Disc, 7.2 mm Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887517081193 FDA UDI
- PMA Number
- P100012 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
Dimensions & Sizes
- Size
- Depth — 17 Millimeter FDA UDIWidth — 20 Millimeter FDA UDIHeight — 7.2 Millimeter FDA UDI
Category: Cervical total intervertebral disc prosthesis, modular
Pcm by Nuvasive, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cervical total intervertebral disc prosthesis, modular.
- 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
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- Mobi-C® Plug & Fit US — Ldr Spine USA · Class III
- Prodisc C — Centinel Spine, LLC · Class III
- ProDisc-C — SYNTHES (U.S.A.) LP · Class III
Cleared under the same submission
P100012 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
- Nuvasive, Inc.
Sources (1)
- FDA UDI 548f9d5d-1762-4742-bcce-a568d730a3d3 36 fields · synced May 30, 2026