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SynPOR

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name
SynPOR FDA UDI
Generic Name
Polyethylene craniofacial tissue reconstructive material FDA UDI
Device Name
SYNPOR ORBITAL FLOOR PLATE 30MM/1.5MM THICK-STERILE FDA UDI
Model / Reference
08.510.544S FDA UDI
Description
SYNPOR ORBITAL FLOOR PLATE 30MM/1.5MM THICK-STERILE FDA UDI

Identifiers

Catalog Number
08510544S FDA UDI
Primary DI / UDI-DI
10887587026190 FDA UDI
510(k) Number
K051879 FDA UDI
FDA Product Code
FTL FDA UDI
FTM FDA UDI
GWO FDA UDI
GMDN Term
Polyethylene craniofacial tissue reconstructive material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
882.5320 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

No

FDA UDI

Category: Polyethylene craniofacial tissue reconstructive material

SynPOR by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyethylene craniofacial tissue reconstructive material.

Cleared under the same submission

K051879 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI 9956fbf6-e720-4a83-8831-0a78be979082 36 fields · synced May 30, 2026