FDA.reportPublic FDA data

NA

Primary DI
10886982308184
Brand
NA
Company
Synthes GmbH
Model
04.170.635S
Catalog number
04170635S
Device description
6.0MM TI SELF-DRILLING SCHANZ SCREW 35MM THRD/175MM/STERILE
Published
2022-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
OSNSoftware for diagnosis/treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2
OSNSoftware For Diagnosis/TreatmentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040701000
K082650000
K122455000
K161417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040701000SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWSSynthes (Usa)2004-06-15HWC
K082650000SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONALSynthes (Usa)2008-11-18KTT
K122455000SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMSynthes2013-04-11KTT
K161417000DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC2016-11-10KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982308184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698230818410886982308184

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
00810112592986TriLEAP04.901.022049010222024-02-22
00810112592993TriLEAP04.901.024049010242024-02-22
00810112593006TriLEAP04.901.026049010262024-02-22
00810112593013TriLEAP04.901.028049010282024-02-22
00810112593020TriLEAP04.901.030049010302024-02-22
00810112593037TriLEAP04.902.008049020082024-02-22
00810112593044TriLEAP04.902.009049020092024-02-22
00810112593051TriLEAP04.902.010049020102024-02-22
00810112593068TriLEAP04.902.011049020112024-02-22
00810112593075TriLEAP04.902.012049020122024-02-22
00810112593082TriLEAP04.902.013049020132024-02-22
00810112593099TriLEAP04.902.014049020142024-02-22
00810112593105TriLEAP04.902.015049020152024-02-22
00810112593112TriLEAP04.902.016049020162024-02-22
00810112593129TriLEAP04.902.018049020182024-02-22
00810112593136TriLEAP04.902.020049020202024-02-22
00810112593143TriLEAP04.902.022049020222024-02-22
00810112593150TriLEAP04.902.024049020242024-02-22
00810112593167TriLEAP04.902.026049020262024-02-22
00810112593174TriLEAP04.902.028049020282024-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112592245TriLEAPSynthes GmbHHWC2024-02-23
00810112592252TriLEAPSynthes GmbHHWC2024-02-23
00810112592429TriLEAPSynthes GmbHHWC2024-02-23
00810112592450TriLEAPSynthes GmbHHWC2024-02-23
00810112592467TriLEAPSynthes GmbHHWC2024-02-23
00810112592474TriLEAPSynthes GmbHHWC2024-02-23
00810112592634TriLEAPSynthes GmbHHWC2024-02-23
00810112592832TriLEAPSynthes GmbHHWC2024-02-23
00810112592849TriLEAPSynthes GmbHHWC2024-02-23
00810112592986TriLEAPSynthes GmbHHWC2024-02-22
00810112592993TriLEAPSynthes GmbHHWC2024-02-22
00810112593006TriLEAPSynthes GmbHHWC2024-02-22
00810112593013TriLEAPSynthes GmbHHWC2024-02-22
00810112593020TriLEAPSynthes GmbHHWC2024-02-22
00810112593037TriLEAPSynthes GmbHHWC2024-02-22
00810112593044TriLEAPSynthes GmbHHWC2024-02-22
00810112593051TriLEAPSynthes GmbHHWC2024-02-22
00810112593068TriLEAPSynthes GmbHHWC2024-02-22
00810112593075TriLEAPSynthes GmbHHWC2024-02-22
00810112593082TriLEAPSynthes GmbHHWC2024-02-22
00810112593099TriLEAPSynthes GmbHHWC2024-02-22
00810112593105TriLEAPSynthes GmbHHWC2024-02-22
00810112593112TriLEAPSynthes GmbHHWC2024-02-22
00810112593129TriLEAPSynthes GmbHHWC2024-02-22
00810112593136TriLEAPSynthes GmbHHWC2024-02-22
00810112593143TriLEAPSynthes GmbHHWC2024-02-22
00810112593150TriLEAPSynthes GmbHHWC2024-02-22
00810112593167TriLEAPSynthes GmbHHWC2024-02-22
00810112593174TriLEAPSynthes GmbHHWC2024-02-22
00810112593181TriLEAPSynthes GmbHHWC2024-02-22