FDA.reportPublic FDA data

Dall-Miles

Primary DI
07613154490301
Brand
Dall-Miles
Company
Howmedica Osteonics Corp.
Model
3704-2-091
Catalog number
3704-2-091
Device description
Trochanteric grip plate
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
07613154490301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613154490301076131544903017613154490301

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
Length110Millimeter

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
04546540273260Orthinox6364-2-0266364-2-0262015-09-24
04546540273291Orthinox6364-2-0326364-2-0322015-09-24
04546540273314Orthinox6364-2-1266364-2-1262015-09-24
04546540273345Orthinox6364-2-1326364-2-1322015-09-24
04546540273369Orthinox6364-2-2266364-2-2262015-09-24
04546540273390Orthinox6364-2-2326364-2-2322015-09-24
04546540402158Orthinox6364-2-3226364-2-3222015-09-24
04546540402165Orthinox6364-2-3266364-2-3262015-09-24
04546540402172Orthinox6364-2-3286364-2-3282015-09-24
04546540402189Orthinox6364-2-3326364-2-3322015-09-24
04546540432001Trident502-11-46C502-11-46C2015-09-24
04546540568083Dall-Miles6704-3-0706704-3-0702015-09-24
04546540568090Dall-Miles6704-3-0806704-3-0802015-09-24
04546540568106Dall-Miles6704-3-0816704-3-0812015-09-24
04546540568113Dall-Miles6704-3-0826704-3-0822015-09-24
04546540568120Dall-Miles6704-3-0836704-3-0832015-09-24
04546540568137Dall-Miles6704-3-0906704-3-0902015-09-24
04546540568144Dall-Miles6704-3-0916704-3-0912015-09-24
04546540568151Dall-Miles6704-3-0926704-3-0922015-09-24
04546540568168Dall-Miles6704-3-0936704-3-0932015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986482501CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482518CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482525CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482532CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482549CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482556CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482563CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482570CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482587CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
03700569602918Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602925Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602932Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602949Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602956Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602963Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602970Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602987Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
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00885556819869Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819876Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819883Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819890Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819906Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819722Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819746Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819760Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819784UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819791UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819807UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26