FDA.reportPublic FDA data

NA

Primary DI
10886982307255
Brand
NA
Company
Synthes GmbH
Model
02.127.175TS
Catalog number
02127175TS
Device description
3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/75MM
Published
2021-04-01
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
10886982307255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698230725510886982307255

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

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
10886982228185NA456.456S456456S2015-09-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809986490032CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
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08809986490056CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490063CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490087CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490094CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490100CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490117CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
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08809986490131CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490148CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490155CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490162CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490179CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490186CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
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08809986490223CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490230CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490247CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
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08809986490285CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490292CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490308CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27