FDA.reportPublic FDA data

NA

Primary DI
10887587055121
Brand
NA
Company
Synthes GmbH
Model
460.036
Catalog number
460036
Device description
TI STERNAL LOCKING STAR PLATE- 12 HOLES
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE
HWCScrew, fixation, bone
JDQCERCLAGE, FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDQCerclage, FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010943000
K093772000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010943000SYNTHES STERNAL FIXATION SYSTEMSynthes (Usa)2001-06-27JDQ
K093772000SYNTHES STERNAL FIXATION SYSTEMSynthes2010-03-29HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587055121PrimaryGS10
H9804600360SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758705512110887587055121

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
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