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CoCr Low Profile Cable System

FDA UDI

Class II (US FDA UDI)

by Signal Medical Corp.

Identity

Trade Name
CoCr Low Profile Cable System FDA UDI
Generic Name
Internal orthopaedic fixation system, cerclage wire/cable, sterile FDA UDI
Device Name
Size: 1.5mm CoCr Low Profile Cable FDA UDI
Model / Reference
1.5mm Cable FDA UDI
Description
Size: 1.5mm CoCr Low Profile Cable FDA UDI

Identifiers

Catalog Number
BIO11012 FDA UDI
Primary DI / UDI-DI
B046BIO110120 FDA UDI
510(k) Number
K951844 FDA UDI
FDA Product Code
JDQ FDA UDI
GMDN Term
Internal orthopaedic fixation system, cerclage wire/cable, sterile 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Internal orthopaedic fixation system, cerclage wire/cable, sterile

CoCr Low Profile Cable System by Signal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal orthopaedic fixation system, cerclage wire/cable, sterile.

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
Signal Medical Corp.

Sources (1)

  • FDA UDI 7b51c1aa-9d2d-4cb4-aada-ac4438fe027a 36 fields · synced Jun 8, 2026