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Matrix

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name
Matrix FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
1.85MM TI MATRIX SCREW/COARSE PITCH/SELF-TAPPING/12MM FDA UDI
Model / Reference
04.511.212.05 FDA UDI
Description
1.85MM TI MATRIX SCREW/COARSE PITCH/SELF-TAPPING/12MM FDA UDI

Identifiers

Catalog Number
0451121205 FDA UDI
Primary DI / UDI-DI
20887587023523 FDA UDI
510(k) Number
K083388 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
Commercial Distribution
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

Category: Orthopaedic bone screw (non-sliding)

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

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

Cleared under the same submission

K083388 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 10af6c5a-1592-4478-8787-d06d81c6d275 36 fields · synced Jun 8, 2026