Dall-Miles

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: Dall-Miles FDA UDI
Generic Name: Orthopaedic bone cerclage cable FDA UDI
Device Name: Stainless Steel Cable Sleeve Set FDA UDI
Model / Reference: 3704-0-510 FDA UDI
Description: Stainless Steel Cable Sleeve Set FDA UDI

Identifiers

Catalog Number: 3704-0-510 FDA UDI
Primary DI / UDI-DI: 07613327036374 FDA UDI
510(k) Number: K202016 FDA UDI
K971741 FDA UDI
FDA Product Code: JDQ FDA UDI
HRS FDA UDI
LRN FDA UDI
LYT FDA UDI
GMDN Term: Orthopaedic bone cerclage cable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3010 FDA UDI
888.3030 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic bone cerclage cable

Dall-Miles by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone cerclage cable.

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SuperCable® Iso-Elastic™ Cerclage System — Kinamed, Inc. · Class II
Accord — Smith & Nephew, Inc. · Class II
Alliant Biotech — Medisurge · Class II
EVOS Cabling System — Pioneer Surgical Technology, Inc. · Class II
Accord — Smith & Nephew, Inc. · Class II
Accord — Smith & Nephew, Inc. · Class II
Alliant Biotech — Medisurge · Class II

Cleared under the same submission

K971741 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 616fc2b9-8e96-4b65-883b-393f10a3a033 36 fields · synced Jun 8, 2026