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Exeter

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name
EXETER FDA UDI
Generic Name
Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI
Device Name
2.5 I M PLUG FDA UDI
Model / Reference
0939-0-114 FDA UDI
Description
2.5 I M PLUG FDA UDI

Identifiers

Catalog Number
0939-0-114 FDA UDI
Primary DI / UDI-DI
04546540167231 FDA UDI
510(k) Number
K173499 FDA UDI
K191414 FDA UDI
K980843 FDA UDI
FDA Product Code
JDI FDA UDI
LZN FDA UDI
GMDN Term
Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3350 FDA UDI
878.3300 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
MRI Safety
MR Conditional FDA UDI

Category: Polymer orthopaedic cement restrictor, non-bioabsorbable

Exeter by Howmedica Osteonics Corp. — Class II — 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

K173499 also covers:

K191414 also covers:

K980843 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 784e8bc6-752d-4bd3-bf93-6af9e62150a5 36 fields · synced May 30, 2026