Accell Connexus

FDA UDI

Class II (US FDA UDI)

by Isotis Orthobiologics, Inc

Identity

Trade Name: Accell Connexus FDA UDI
Generic Name: Bone matrix implant, human-derived FDA UDI
Device Name: Accell Connexus, 5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package FDA UDI
Model / Reference: 02-3000-050 FDA UDI
Description: Accell Connexus, 5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package FDA UDI

Identifiers

Catalog Number: 02-3000-050 FDA UDI
Primary DI / UDI-DI: 10889981055486 FDA UDI
FDA Product Code: MBP FDA UDI
MQV FDA UDI
GMDN Term: Bone matrix implant, human-derived 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

Yes

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Bone matrix implant, human-derived

Accell Connexus by Isotis Orthobiologics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, human-derived.

Vivex DBM Plus — Hans Biomed Corporation · Class II
DBM Putty 10.0cc Jar — Xtant Medical Holdings, Inc. · Class II
DBM Putty 10.0cc in a Syringe — Xtant Medical Holdings, Inc. · Class II
OsteoSelect (DBM) Putty 5.0cc in a Syringe — Xtant Medical Holdings, Inc. · Class II
InterGro DBM Paste — Biomet Orthopedics, Inc. · Class II
GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Trel-X Putty — Integra Lifesciences Corp. · Class II
Puros® — ZIMMER SPINE, INC. · Class II

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: Isotis Orthobiologics, Inc

Sources (1)

FDA UDI 530a0c03-3512-4a04-b3d9-8acd60d445a9 37 fields · synced Jun 1, 2026