FDA.reportPublic FDA data

NA

Primary DI
10705034739342
Brand
NA
Company
Synthes GmbH
Model
04.614.520
Catalog number
04614520
Device description
TI TOP LOADING TRANSCONNECTOR X-LARGE
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKGOrthosis, cervical pedicle screw spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090549000
K091689000
K141897000
K142460000
K142838000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090549000SYNTHES SYNAPSE TRANSCONNECTORSynthes Spine2009-05-21KWP
K091689000SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MMSynthes (Usa)2009-07-10KWP
K141897000SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEMSynthes USA Products, LLC2014-09-25KWP
K142460000EXPEDIUM Spine System/Synapse SystemJohnson and Johnson2014-10-01KWP
K142838000Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC2015-01-20NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034739342PrimaryGS10
H981046145200SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503473934210705034739342

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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
10705034764030NA291.991.01S29199101S2015-09-14
10705034764047NA291.992.01S29199201S2015-09-14
10705034769097NA321.1313211312016-12-31
10705034769134NA321.7453217452016-12-31
10705034784786NA491.991.01S49199101S2015-09-14
10705034784793NA491.992.01S49199201S2015-09-14
10886982198167NA391.1083911082016-12-31
10886982198204NA391.2013912012016-12-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719IST80030C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80030C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80035C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80035C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80070C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80070C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80075C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80075C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80080C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80080C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80085C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80085C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80090C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80090C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80095C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80095C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80100C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80100C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18