FDA.reportPublic FDA data

DHS

Primary DI
10886982175281
Brand
DHS
Company
Synthes GmbH
Model
280.315S
Catalog number
280315S
Device description
DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/115MM-STERILE
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDODEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDODevice, Fixation, Proximal Femoral, ImplantOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964259000SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATIONSynthes (Usa)1997-01-09JDO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982175281PrimaryGS10
H679280315S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698217528110886982175281

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903993241486130° Wise-Lock DHS Plate, 2 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08903993241493130° Wise-Lock DHS Plate, 3 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
08051739535730ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-10
08059386747391DOLPHIXCITIEFFE SRLKTT2025-04-02
10080196692729MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692866MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
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10080196692927MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
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10080196692965MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
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10193489002072MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002089MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002096MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002102MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002119MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002126MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002133MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002140MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002157MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002164MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002171MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002188MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002195MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002201MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002218MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002225MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002232MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11