FDA.reportPublic FDA data

NA

Primary DI
10886982307231
Brand
NA
Company
Synthes GmbH
Model
02.127.165TS
Catalog number
02127165TS
Device description
3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/65MM
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
10886982307231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698230723110886982307231

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
10887587078540NASD03.501.442SD035014422026-07-29
10886982362179NASD03.043.006SD030430062026-07-24
10887587078557NASD03.503.067SD035030672026-07-24
10887587078564NASD03.503.072SD035030722026-07-24
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00688346003918Fine TTOLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
B562PKSMC0635NSLTI0WishBone Plate & Screw SystemWishbone Medical, Inc.HRS2021-09-07
B562PKSMC0635NSRTI0WishBone Plate & Screw SystemWishbone Medical, Inc.HRS2021-09-07
B562MPKCSST4036T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4036TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4038T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4038TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4040T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4040TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4042T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4042TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4044T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4044TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4050T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4050TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562PKTCX27LG0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX27LGUS0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX27SM0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX27SMUS0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX35LG0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX35LGUS0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX35SM0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02