Dynagraft II Gel

FDA UDI

Class II (US FDA UDI)

by Isotis Orthobiologics, Inc

Identity

Trade Name: Dynagraft II Gel FDA UDI
Generic Name: Bone matrix implant, human-derived FDA UDI
Device Name: DynaGraft II Gel, 0.5cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a gel or putty-like consistency. FDA UDI
Model / Reference: 02-2000-005 FDA UDI
Description: DynaGraft II Gel, 0.5cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a gel or putty-like consistency. FDA UDI

Identifiers

Catalog Number: 02-2000-005 FDA UDI
Primary DI / UDI-DI: 10889981055509 FDA UDI
510(k) Number: K040419 FDA UDI
FDA Product Code: 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

Dynagraft II Gel 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

Cleared under the same submission

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 b20f3472-de6a-4ffc-a454-f8bdf14e3b92 38 fields · synced May 30, 2026