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Particulate 15.0cc

FDA UDI

Class II (US FDA UDI)

by NovaBone Products, LLC

Identity

Trade Name
Particulate 15.0cc FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
Synthetic bone void filler for orthopedic applications FDA UDI
Model / Reference
NB0715 FDA UDI
Description
Synthetic bone void filler for orthopedic applications FDA UDI

Identifiers

Catalog Number
NB0715 FDA UDI
Primary DI / UDI-DI
00813909010892 FDA UDI
510(k) Number
K052494 FDA UDI
FDA Product Code
MQV FDA UDI
GMDN Term
Bone matrix implant, synthetic, non-antimicrobial 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

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

Category: Bone matrix implant, synthetic, non-antimicrobial

Particulate 15.0cc by NovaBone Products, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, synthetic, non-antimicrobial.

Cleared under the same submission

K052494 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NovaBone Products, LLC

Sources (1)

  • FDA UDI b460f3e9-14ab-451f-85a0-80a92d6ec9a9 37 fields · synced Jun 9, 2026