FDA.reportPublic FDA data

NA

Primary DI
10886982196460
Brand
NA
Company
Synthes GmbH
Model
357.428
Catalog number
357428
Device description
TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092646000SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREWSynthes (Usa)2009-09-25HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819456945Direct MarkingGS10
10886982196460PrimaryGS10
H6793574280SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819456945076118194569457611819456945
1088698219646010886982196460

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

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
00810112599275TriLEAP04.900.251049002512025-03-20
00810112599169TriLEAP04.900.240049002402025-03-18
00810112599763TriLEAP03.900.407039004072025-03-18
00810112599176TriLEAP04.900.241049002412025-03-17
00810112599183TriLEAP04.900.242049002422025-03-17
00810112599190TriLEAP04.900.243049002432025-03-17
00810112599206TriLEAP04.900.244049002442025-03-17
00810112599213TriLEAP04.900.245049002452025-03-17
00810112599220TriLEAP04.900.246049002462025-03-17
00810112599237TriLEAP04.900.247049002472025-03-17
00810112599244TriLEAP04.900.248049002482025-03-17
00810112599251TriLEAP04.900.249049002492025-03-17
00810112599268TriLEAP04.900.250049002502025-03-17
00810112592467TriLeap Lower Etremity Anatomic Plating System60.900.307609003072024-02-23
00810112592528TriLeap Lower Extremity Anatomic Plating03.900.311039003112024-02-23
00810112592566TriLeap Lower Etremity Anatomic Plating System03.900.332039003322024-02-23
00810112597035TriLeap Lower Extremity Plating System04.900.057049000572024-02-21
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112599275TriLEAPSynthes GmbHHWC2025-03-20
00810112599169TriLEAPSynthes GmbHHWC2025-03-18
00810112599176TriLEAPSynthes GmbHHWC2025-03-17
00810112599183TriLEAPSynthes GmbHHWC2025-03-17
00810112599190TriLEAPSynthes GmbHHWC2025-03-17
00810112599206TriLEAPSynthes GmbHHWC2025-03-17
00810112599213TriLEAPSynthes GmbHHWC2025-03-17
00810112599220TriLEAPSynthes GmbHHWC2025-03-17
00810112599237TriLEAPSynthes GmbHHWC2025-03-17
00810112599244TriLEAPSynthes GmbHHWC2025-03-17
00810112599251TriLEAPSynthes GmbHHWC2025-03-17
00810112599268TriLEAPSynthes GmbHHWC2025-03-17
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592450TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592467TriLeap Lower Etremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592474TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592634TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592832TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592986TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593006TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593013TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593020TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593037TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593044TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593051TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593068TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22