FDA.reportPublic FDA data

Dall-Miles

Primary DI
07613154490240
Brand
Dall-Miles
Company
Howmedica Osteonics Corp.
Model
3704-2-070
Catalog number
3704-2-070
Device description
Trochanteric grip
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
K070170000
K202016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070170000DALL-MILES SYSTEMStryker Orthopaedics2007-03-02HRS
K202016000Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2020-10-16JDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613154490240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613154490240076131544902407613154490240

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbableAn assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327036503Triathlon5585-C-0165585-C-0162015-09-24
07613327036510Triathlon5585-C-0205585-C-0202015-09-24
07613327036527Triathlon5585-C-0255585-C-0252015-09-24
07613327036534Triathlon5585-C-0305585-C-0302015-09-24
07613327036541Triathlon5585-C-0355585-C-0352015-09-24
07613327036558Triathlon5585-C-0405585-C-0402015-09-24
07613327036565Triathlon5585-C-0455585-C-0452015-09-24
07613327036572Triathlon5585-C-0505585-C-0502015-09-24
07613327036589Triathlon5585-C-0555585-C-0552015-09-24
07613327036596Triathlon5585-C-0605585-C-0602015-09-24
07613327041071Triathlon5520-M-1005520-M-1002015-09-24
07613327041095Triathlon5520-M-2005520-M-2002015-09-24
07613327041101Triathlon5520-M-3005520-M-3002015-09-24
07613327041118Triathlon5520-M-4005520-M-4002015-09-24
07613327041125Triathlon5520-M-5005520-M-5002015-09-24
07613327041132Triathlon5520-M-6005520-M-6002015-09-24
07613327041149Triathlon5520-M-7005520-M-7002015-09-24
07613327041156Triathlon5520-M-8005520-M-8002015-09-24
07613327041392Triathlon5527-B-1005527-B-1002015-09-24
07613327041408Triathlon5527-B-3005527-B-3002015-09-24

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