FormaGraft

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name: FormaGraft FDA UDI
Generic Name: Bone matrix implant, composite FDA UDI
Device Name: FormaGraft® XL Blocks, Small FDA UDI
Model / Reference: 5010085 FDA UDI
Description: FormaGraft® XL Blocks, Small FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517238450 FDA UDI
510(k) Number: K050789 FDA UDI
FDA Product Code: MQV FDA UDI
GMDN Term: Bone matrix implant, composite 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

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bone matrix implant, composite

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

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MacroFORM Bioactive Packable Graft 5.0cc — NovaBone Products, LLC · Class II

Cleared under the same submission

K050789 also covers:

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: Nuvasive, Inc.

Sources (1)

FDA UDI 72f04ec5-1aae-4803-b211-81ed7238778c 35 fields · synced Jun 7, 2026