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Plug

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name
Plug FDA UDI
Generic Name
Orthopaedic cement spacer FDA UDI
Device Name
Distal Hole Plug FDA UDI
Model / Reference
1067-0002 FDA UDI
Description
Distal Hole Plug FDA UDI

Identifiers

Catalog Number
1067-0002 FDA UDI
Primary DI / UDI-DI
07613327013887 FDA UDI
510(k) Number
K992462 FDA UDI
FDA Product Code
LZN FDA UDI
GMDN Term
Orthopaedic cement spacer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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: Orthopaedic cement spacer

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

Similar devices

Also classified as Orthopaedic cement spacer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 86b2962a-50a2-4846-a30a-df60f845cce2 35 fields · synced Jun 1, 2026