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Bone Plug

FDA UDI

Class III (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name
Bone Plug FDA UDI
Generic Name
Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI
Device Name
Sized Cement Plug FDA UDI
Model / Reference
B003-0140 FDA UDI
Description
Sized Cement Plug FDA UDI

Identifiers

Catalog Number
B003-0140 FDA UDI
Primary DI / UDI-DI
04546540007919 FDA UDI
510(k) Number
K926216 FDA UDI
FDA Product Code
LTO FDA UDI
GMDN Term
Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
888.3320 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Polymer orthopaedic cement restrictor, non-bioabsorbable

Bone Plug by Howmedica Osteonics Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymer orthopaedic cement restrictor, non-bioabsorbable.

Cleared under the same submission

K926216 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Howmedica Osteonics Corp.

Sources (1)

  • FDA UDI c7e3b990-c3d4-4f5a-b839-01937cd9934c 36 fields · synced May 30, 2026