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STRATOFUSE Strip

FDA UDI

Class II (US FDA UDI)

by Berkeley Advanced Biomaterials

Identity

Trade Name
STRATOFUSE Strip FDA UDI
Generic Name
Bone matrix implant, composite FDA UDI
Device Name
STRATOFUSE is a sterile bone graft composed of purified fibrillar type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device, formulated as a block (strip), is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. STRATOFUSE is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30ml. FDA UDI
Model / Reference
BA42-501005 FDA UDI
Description
STRATOFUSE is a sterile bone graft composed of purified fibrillar type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device, formulated as a block (strip), is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. STRATOFUSE is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30ml. FDA UDI

Identifiers

Catalog Number
BA42-501005 FDA UDI
Primary DI / UDI-DI
00858418003997 FDA UDI
510(k) Number
K092046 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bone matrix implant, composite

STRATOFUSE Strip by Berkeley Advanced Biomaterials — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, composite.

Cleared under the same submission

K092046 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Berkeley Advanced Biomaterials

Sources (1)

  • FDA UDI a6d31e92-de19-4a11-80ca-08da66626105 35 fields · synced May 30, 2026