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Pcm

FDA UDI

Class III (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
PCM FDA UDI
Generic Name
Cervical total intervertebral disc prosthesis, modular FDA UDI
Device Name
PCM V Disc, 5.9mm Medium (US) FDA UDI
Model / Reference
7680359 FDA UDI
Description
PCM V Disc, 5.9mm Medium (US) FDA UDI

Identifiers

Primary DI / UDI-DI
00887517601155 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

Yes

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.

Cleared under the same submission

P100012 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI e533f5df-e0b8-4b10-af26-57ca6a13fee8 35 fields · synced May 30, 2026