Plexur P®

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: PLEXUR P® FDA UDI
Generic Name: Bone matrix implant, human-derived FDA UDI
Device Name: GRANULES 60000020INT PLEXUR P 20 CC FDA UDI
Model / Reference: 60000020INT FDA UDI
Description: GRANULES 60000020INT PLEXUR P 20 CC FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169218253 FDA UDI
510(k) Number: K080511 FDA UDI
FDA Product Code: MQV FDA UDI
GMDN Term: Bone matrix implant, human-derived FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3045 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

Yes

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Bone matrix implant, human-derived

Plexur P® by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, human-derived.

Vivex DBM Plus — Hans Biomed Corporation · Class II
DBM Putty 10.0cc Jar — Xtant Medical Holdings, Inc. · Class II
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OsteoSelect (DBM) Putty 5.0cc in a Syringe — Xtant Medical Holdings, Inc. · Class II
InterGro DBM Paste — Biomet Orthopedics, Inc. · Class II
Trel-X Putty — Integra Lifesciences Corp. · Class II
Puros® — ZIMMER SPINE, INC. · Class II
BioSet® — Rti Surgical, Inc. · Class II

Cleared under the same submission

K080511 also covers:

PLEXUR P® — MEDTRONIC SOFAMOR DANEK, INC.

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 II	Pending data

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Manufacturer

Manufacturer: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI 0bc91eab-8e79-4ee8-86b1-24954f182cdd 36 fields · synced May 30, 2026