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OrthoMesh

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name
OrthoMesh FDA UDI
Generic Name
Bioabsorbable orthopaedic bone screw FDA UDI
Device Name
1.5MM RESORBABLE CORTEX SCREW 5MM FOR ORTHOMESH-STERILE FDA UDI
Model / Reference
803.605.02S FDA UDI
Description
1.5MM RESORBABLE CORTEX SCREW 5MM FOR ORTHOMESH-STERILE FDA UDI

Identifiers

Catalog Number
80360502S FDA UDI
Primary DI / UDI-DI
20886982255935 FDA UDI
510(k) Number
K073115 FDA UDI
FDA Product Code
HRS FDA UDI
HWC FDA UDI
GMDN Term
Bioabsorbable orthopaedic bone screw FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3040 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: Bioabsorbable orthopaedic bone screw

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

Similar devices

Also classified as Bioabsorbable orthopaedic bone screw.

Cleared under the same submission

K073115 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 312cc5db-569f-4aeb-9441-634783eee853 37 fields · synced May 30, 2026