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AlexiGlass Bioactive Glass Strip

FDA UDI

Class II (US FDA UDI)

by Berkeley Advanced Biomaterials

Identity

Trade Name
AlexiGlass Bioactive Glass Strip FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
AlexiGlass Bioactive Glass Strip is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive. AlexiGlass Bioactive Glass Strip is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. AlexiGlass Bioactive Glass Strip must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. FDA UDI
Model / Reference
AB-3508 FDA UDI
Description
AlexiGlass Bioactive Glass Strip is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive. AlexiGlass Bioactive Glass Strip is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. AlexiGlass Bioactive Glass Strip must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. FDA UDI

Identifiers

Catalog Number
AB-3508 FDA UDI
Primary DI / UDI-DI
00816125025527 FDA UDI
510(k) Number
K170917 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bone matrix implant, synthetic, non-antimicrobial

AlexiGlass Bioactive Glass 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, synthetic, non-antimicrobial.

Cleared under the same submission

K170917 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 610704f8-a03d-419b-b343-1836abe8e107 35 fields · synced Jun 6, 2026