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ISO adapter for Surgical wrench

FDA UDI

Class II (US FDA UDI)

by Cochlear Bone Anchored Solutions AB

Identity

Trade Name
ISO adapter for Surgical wrench FDA UDI
Generic Name
General external orthopaedic fixation system implantation kit, reusable FDA UDI
Device Name
N/A FDA UDI
Model / Reference
92353 FDA UDI
Description
N/A FDA UDI

Identifiers

Catalog Number
92353 FDA UDI
Primary DI / UDI-DI
09321502019804 FDA UDI
510(k) Number
K955713 FDA UDI
FDA Product Code
LXB FDA UDI
GMDN Term
General external orthopaedic fixation system implantation kit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3302 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

ISO adapter for Surgical wrench by Cochlear Bone Anchored Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K955713 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cochlear Bone Anchored Solutions AB

Sources (1)

  • FDA UDI 42fbe6dc-9ad4-4507-a89f-be7984521ded 37 fields · synced May 30, 2026