FDA.reportPublic FDA data

NA

Primary DI
H679400820960
Brand
NA
Company
Synthes GmbH
Model
400.820.96
Catalog number
40082096
Device description
1.5MM TI CORTEX SCREW SELF-TAPPING 20MM
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZLSCREW, FIXATION, INTRAOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980199000SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSSynthes (Usa)1998-04-17DZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982203830PrimaryGS10
H679400820960SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698220383010886982203830

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982363541NASD351.724SD3517242026-11-05
10886982278746NA60.133.023601330232026-11-03
10886982346421NA60.133.182601331822026-11-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817421023668X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023675X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023682X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023699X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023705X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023712X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023729X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023736X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023743X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023750X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023767X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023774X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023781X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023798X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00083208006159Tatum Surgical Bone Fixation ScrewSuncoast Dental, IncDZL2026-08-14
00083208006166Tatum Surgical Bone Fixation ScrewSuncoast Dental, IncDZL2026-08-14
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08800089458967Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
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08800089458981Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458998Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089459001Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
ESAM23053121STOMA®Storz am Mark GmbHDZL2025-04-30
ESAM23060091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12