FDA.reportPublic FDA data

Dall-Miles

Primary DI
07613327036480
Brand
Dall-Miles
Company
Howmedica Osteonics Corp.
Model
6704-8-236
Catalog number
6704-8-236
Device description
Cable
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
JDQCERCLAGE, FIXATION
LRNWire, surgical
LYTFIXATION ACCESSORY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
JDQCerclage, FixationOrthopedic2
LRNWire, SurgicalOrthopedic2
LYTFixation AccessoryOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202016000
K240418000
K945294000
K961283000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202016000Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2020-10-16JDQ
K240418000Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2024-04-12JDI
K945294000DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLEHowmedica Corp.1995-03-07JDQ
K961283000DALL-MILES HOMOGENOUS VITALLIUM CABLEHowmedica Corp.1996-05-22JDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327036480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327036480076133270364807613327036480

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone cerclage cableAn implantable braided metallic cord intended to be tightened with a crimp-like component to form a loop or ring around a fractured bone and/or fixation plate as part of an orthopaedic treatment. It is not rigid (i.e., not a pin/K-wire) and not intended to be used in spinal bones. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length0

Regulatory Flags#

DUNS number
058311945
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327036176Washer6290-8-6206290-8-6202015-09-24
07613327101072Unix4510-001L4510-001L2015-09-24
07613327101096Unix4510-003L4510-003L2015-09-24
07613327101119Unix4510-001R4510-001R2015-09-24
07613327101126Unix4510-003R4510-003R2015-09-24
07613327101133Unix4510-002R4510-002R2015-09-24
07613327101140Unix4510-002L4510-002L2015-09-24
07613327337150Triathlon5531-G-409-E5531-G-409-E2018-06-27
07613327027730Triathlon5610-F-1015610-F-1012015-09-24
07613327027747Triathlon5610-F-2015610-F-2012015-09-24
07613327027754Triathlon5610-F-1025610-F-1022015-09-24
07613327027761Triathlon5610-F-2025610-F-2022015-09-24
07613327027778Triathlon5610-F-3015610-F-3012015-09-24
07613327027785Triathlon5610-F-3025610-F-3022015-09-24
07613327027792Triathlon5610-F-4015610-F-4012015-09-24
07613327027808Triathlon5610-F-4025610-F-4022015-09-24
07613327027815Triathlon5610-F-5025610-F-5022015-09-24
07613327027822Triathlon5610-F-6015610-F-6012015-09-24
07613327027839Triathlon5610-F-6025610-F-6022015-09-24
07613327027846Triathlon5610-F-5015610-F-5012015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810136433593OptimalMTP®Forma Medical, Inc.HRS2026-10-16
00810136433609OptimalMTP®Forma Medical, Inc.HRS2026-10-16
05055662976649Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976656Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976663Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976670Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976687Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569631857Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
00888118132529LEVEL ONE EXTREMITYKLS-Martin L.P.HRS2026-04-23
08809986482815CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482822CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482839CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482846CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482853CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482860CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482778CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-21
08809986482785CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-21
08809986482716CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482723CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482730CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482747CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482754CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482761CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
00810112599268TriLEAPCROSSROADS EXTREMITY SYSTEMSHRS2025-03-17
00810112593341TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHRS2024-02-22
00885556838211Total Foot System 2Smith & Nephew, Inc.HRS2023-04-18
B562PKSMC0835NSLTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, LeftWishbone Medical, Inc.HRS2019-09-06
B562PKSMC0835NSRTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, RightWishbone Medical, Inc.HRS2019-09-06