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Alliant Biotech

FDA UDI

Class II (US FDA UDI)

by Medisurge

Identity

Trade Name
Alliant Biotech FDA UDI
Generic Name
Orthopaedic bone cerclage cable FDA UDI
Device Name
Low Profile Cable System FDA UDI
Model / Reference
BIO-1-1012 FDA UDI
Description
Low Profile Cable System FDA UDI

Identifiers

Catalog Number
BIO-1-1012 FDA UDI
Primary DI / UDI-DI
G611BIO110120 FDA UDI
510(k) Number
K951844 FDA UDI
FDA Product Code
JDQ FDA UDI
GMDN Term
Orthopaedic bone cerclage cable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3010 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: Orthopaedic bone cerclage cable

Alliant Biotech by Medisurge — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone cerclage cable.

Cleared under the same submission

K951844 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medisurge

Sources (1)

  • FDA UDI 1768a5bd-136c-4fab-809b-14fe28de8a09 36 fields · synced Jun 8, 2026