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Axsos

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
AXSOS FDA UDI
Generic Name
Orthopaedic bone cerclage wire FDA UDI
Device Name
Cable Plug FDA UDI
Model / Reference
370005 FDA UDI
Description
Cable Plug FDA UDI

Identifiers

Catalog Number
370005 FDA UDI
Primary DI / UDI-DI
07613154089505 FDA UDI
510(k) Number
K092178 FDA UDI
FDA Product Code
HRS FDA UDI
HWC FDA UDI
GMDN Term
Orthopaedic bone cerclage wire 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

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 cerclage wire

Axsos by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone cerclage wire.

Cleared under the same submission

K092178 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI a7bafc5a-249e-4a23-957e-393b80d1f77f 35 fields · synced May 30, 2026