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Medpor

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
MEDPOR FDA UDI
Generic Name
Mandibular condyle prosthesis FDA UDI
Device Name
Mandibular Angle Ramus W/Infer. Ridge ES-5 - Right FDA UDI
Model / Reference
7542 FDA UDI
Description
Mandibular Angle Ramus W/Infer. Ridge ES-5 - Right FDA UDI

Identifiers

Catalog Number
7542 FDA UDI
Primary DI / UDI-DI
07613252083979 FDA UDI
510(k) Number
K922489 FDA UDI
FDA Product Code
FWP FDA UDI
GMDN Term
Mandibular condyle prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3550 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 79.0 Millimeter FDA UDI
Height — 32.0 Millimeter FDA UDI
Width — 5.0 Millimeter FDA UDI

Category: Mandibular condyle prosthesis

Medpor by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mandibular condyle prosthesis.

Cleared under the same submission

K922489 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI 84dd3899-a737-4cb6-bcfa-734a4162074a 36 fields · synced May 31, 2026