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Pcm

FDA UDI

Class III (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
PCM FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
PCM Trial, 8.0 mm Cervical Disc, Small FDA UDI
Model / Reference
7691280 FDA UDI
Description
PCM Trial, 8.0 mm Cervical Disc, Small FDA UDI

Identifiers

Primary DI / UDI-DI
00887517084019 FDA UDI
PMA Number
P100012 FDA UDI
FDA Product Code
MJO FDA UDI
GMDN Term
Spinal implant trial 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Depth — 17 Millimeter FDA UDI
Width — 14 Millimeter FDA UDI
Height — 8 Millimeter FDA UDI

Category: Spinal implant trial

Pcm by Nuvasive, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

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 6c9fee43-a03c-4194-a088-6ceede85351d 36 fields · synced May 31, 2026