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MatrixMANDIBLE

FDA UDI

Class II (US FDA UDI)

by Synthes (u.s.a.) Lp

Identity

Trade Name
MatrixMANDIBLE FDA UDI
Generic Name
Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Device Name
TI MATRIXMANDIBLE TENSION BAND 2X2H/RIGID/1.25MM THICK FDA UDI
Model / Reference
SD448.014 FDA UDI
Description
TI MATRIXMANDIBLE TENSION BAND 2X2H/RIGID/1.25MM THICK FDA UDI

Identifiers

Catalog Number
SD448014 FDA UDI
Primary DI / UDI-DI
10887587004419 FDA UDI
510(k) Number
K063790 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

MatrixMANDIBLE by Synthes (u.s.a.) Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K063790 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes (u.s.a.) Lp

Sources (1)

  • FDA UDI aa099001-bb6d-44c5-90b8-8f8cd6f46875 37 fields · synced May 30, 2026