FDA.reportPublic FDA data

TriLEAP

Primary DI
00810112593143
Brand
TriLEAP
Company
Synthes GmbH
Model
04.902.022
Catalog number
04902022
Device description
TriLEAP(TM) 2.0 mm Ti Variable Angle Screw Length 22 mm, Blue
Published
2024-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
K230591000
K253178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230591000TriLEAP Plating SystemCrossroads Extremity Systems2023-09-29HRS
K253178000TRILEAP Plating SystemCrossroads Extremity Systems2026-01-06HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112593143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112593143008101125931438101125931430810112593143

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
480426451
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
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
00810112593150TriLEAP04.902.024049020242024-02-22
00810112593167TriLEAP04.902.026049020262024-02-22
00810112593174TriLEAP04.902.028049020282024-02-22
00810112593181TriLEAP04.902.030049020302024-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112592245TriLEAPSynthes GmbHHRS2024-02-23
00810112592245TriLEAPSynthes GmbHHWC2024-02-23
00810112592252TriLEAPSynthes GmbHHWC2024-02-23
00810112592252TriLEAPSynthes GmbHHRS2024-02-23
00810112592429TriLEAPSynthes GmbHHWC2024-02-23
00810112592429TriLEAPSynthes GmbHHRS2024-02-23
00810112592450TriLEAPSynthes GmbHHWC2024-02-23
00810112592450TriLEAPSynthes GmbHHRS2024-02-23
00810112592467TriLEAPSynthes GmbHHWC2024-02-23
00810112592467TriLEAPSynthes GmbHHRS2024-02-23
00810112592474TriLEAPSynthes GmbHHWC2024-02-23
00810112592474TriLEAPSynthes GmbHHRS2024-02-23
00810112592634TriLEAPSynthes GmbHHWC2024-02-23
00810112592634TriLEAPSynthes GmbHHRS2024-02-23
00810112592832TriLEAPSynthes GmbHHRS2024-02-23
00810112592832TriLEAPSynthes GmbHHWC2024-02-23
00810112592849TriLEAPSynthes GmbHHWC2024-02-23
00810112592849TriLEAPSynthes GmbHHRS2024-02-23
00810112592986TriLEAPSynthes GmbHHRS2024-02-22
00810112592986TriLEAPSynthes GmbHHWC2024-02-22
00810112592993TriLEAPSynthes GmbHHRS2024-02-22
00810112592993TriLEAPSynthes GmbHHWC2024-02-22
00810112593006TriLEAPSynthes GmbHHRS2024-02-22
00810112593006TriLEAPSynthes GmbHHWC2024-02-22
00810112593013TriLEAPSynthes GmbHHRS2024-02-22
00810112593013TriLEAPSynthes GmbHHWC2024-02-22
00810112593020TriLEAPSynthes GmbHHRS2024-02-22
00810112593020TriLEAPSynthes GmbHHWC2024-02-22
00810112593037TriLEAPSynthes GmbHHRS2024-02-22
00810112593037TriLEAPSynthes GmbHHWC2024-02-22