FDA.reportPublic FDA data

NA

Primary DI
10886982306654
Brand
NA
Company
Synthes GmbH
Model
02.127.190TS
Catalog number
02127190TS
Device description
3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/90MM
Published
2025-01-31
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
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120689000
K120854000
K121601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120689000SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEMSynthes (USA) Products, LLC2012-06-04HRS
K120854000SYNTHES VA LCP ANKLE TRAUMA SYSTEMSynthes USA2012-06-18HRS
K121601000SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATESynthes USA2012-07-06HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982306654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698230665410886982306654

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
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008405368000393P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000463P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
10850070500125CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500132CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500149CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500156CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500163CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500170CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500187CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500194CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500200CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500217CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500224CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500231CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500248CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500255CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500262CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500279CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500286CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500293CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500309CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500316CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500323CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500330CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500347CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500354CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22