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MatrixMIDFACE

FDA UDI

Class II (US FDA UDI)

by Synthes (u.s.a.) Lp

Identity

Trade Name
MatrixMIDFACE FDA UDI
Generic Name
Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Device Name
TI MATRIXMIDFACE OBLIQUE L-PL 18MM/2X2 H/LEFT/0.7MM THICK FDA UDI
Model / Reference
SD445.003 FDA UDI
Description
TI MATRIXMIDFACE OBLIQUE L-PL 18MM/2X2 H/LEFT/0.7MM THICK FDA UDI

Identifiers

Catalog Number
SD445003 FDA UDI
Primary DI / UDI-DI
10887587003320 FDA UDI
510(k) Number
K050608 FDA UDI
FDA Product Code
DZL FDA UDI
JEY FDA UDI
GMDN Term
Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4880 FDA UDI
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

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

Cleared under the same submission

K050608 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 93c00d45-3f44-4411-afc0-984e5c141a4e 37 fields · synced Jun 1, 2026