OsteoGen Plugs - Large, 10x20mm

FDA UDI

Class II (US FDA UDI)

by Impladent

Identity

Trade Name: OsteoGen Plugs - Large, 10x20mm FDA UDI
Generic Name: Composite bone graft FDA UDI
Device Name: OsteoGen Plugs. OsteoGen bone graft combined with a bovine achilles tendon carrier. FDA UDI
Model / Reference: OPL1020 FDA UDI
Description: OsteoGen Plugs. OsteoGen bone graft combined with a bovine achilles tendon carrier. FDA UDI

Identifiers

Primary DI / UDI-DI: 00855286006013 FDA UDI
510(k) Number: K090794 FDA UDI
FDA Product Code: NPM FDA UDI
GMDN Term: Composite bone graft FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3930 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

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

Category: Composite bone graft

OsteoGen Plugs - Large, 10x20mm by Impladent — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Composite bone graft.

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CONDUCT — GLOBUS MEDICAL, INC. · Class II
VENADO Carbonate Apatite Block — COLLAGEN MATRIX, INC. · Class II
VENADO Carbonate Apatite Strip — COLLAGEN MATRIX, INC. · Class II
CONDUCT — GLOBUS MEDICAL, INC. · Class II
PlatFORM CM Strip — COLLAGEN MATRIX, INC. · Class II

Cleared under the same submission

K090794 also covers:

OsteoGen Block — Impladent
OsteoGen Plugs - Extra Large — Impladent
OsteoGen Plugs - Slim, 6x25mm — Impladent
OsteoGen Strip — Impladent
OsteoGen Strip - Small — Impladent

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: Impladent

Sources (1)

FDA UDI cc034d44-3344-4750-a4eb-eb1257b8ed15 34 fields · synced Jun 8, 2026