Vitoss

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: Vitoss FDA UDI
Generic Name: Bone matrix implant, composite FDA UDI
Device Name: Bone Graft Substitute, Foam Strip, Beta-Tricalcium Phosphate and Type I Bovine Collagen FDA UDI
Model / Reference: 2102-1110 FDA UDI
Description: Bone Graft Substitute, Foam Strip, Beta-Tricalcium Phosphate and Type I Bovine Collagen FDA UDI

Identifiers

Catalog Number: 2102-1110 FDA UDI
Primary DI / UDI-DI: 00808232000306 FDA UDI
510(k) Number: K032288 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

FDA UDI

Dimensions & Sizes

Size: Width — 25.0 Millimeter FDA UDI
Height — 8.0 Millimeter FDA UDI
Length — 50.0 Millimeter FDA UDI

Category: Bone matrix implant, composite

Vitoss by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, composite.

nanOss Loaded Advanced Bone Graft Substitute Kit — Xtant Medical Holdings, Inc. · Class II
CopiOs® Bone Void Filler Paste — DSM BIOMEDICAL, INC. · Class II
STRATOFUSE Strip — Berkeley Advanced Biomaterials · Class II
OptiFuse Bi-Ostetic Foam Strip — Berkeley Advanced Biomaterials · Class II
AlexiFuse Synthetic Foam Strip — Berkeley Advanced Biomaterials · Class II
BiSyntek Putty — Berkeley Advanced Biomaterials · Class II
MacroFORM Bioactive Packable Graft 5.0cc — NovaBone Products, LLC · Class II
nanOss 3D Plus Advanced Bone Graft Substitute — Xtant Medical Holdings, Inc. · Class II

Cleared under the same submission

K032288 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: Stryker Corp.

Sources (1)

FDA UDI 49589959-9b80-4630-bab0-36ef15428e74 38 fields · synced Jun 1, 2026