Identity
- Trade Name
- Mobi-C Plug & Fit US FDA UDI
- Generic Name
- Cervical total intervertebral disc prosthesis, modular FDA UDI
- Device Name
- US MOBI-C M"STANDARD" IMPLANT 13x15 H4.5 FDA UDI
- Model / Reference
- MB3354 FDA UDI
- Description
- US MOBI-C M"STANDARD" IMPLANT 13x15 H4.5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03662663059053 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
Dimensions & Sizes
- Size
- Depth — 13 Millimeter FDA UDI
Category: Cervical total intervertebral disc prosthesis, modular
Mobi-C Plug & Fit US by Zimmer Biomet — 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
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
- Zimmer Biomet
Sources (1)
- FDA UDI 13820fb9-b9f0-40be-8eec-8b7c6d8a271a 35 fields · synced May 30, 2026