FDA.reportPublic FDA data

VA-LCP

Primary DI
H679031075080
Brand
VA-LCP
Company
Synthes GmbH
Model
03.107.508
Catalog number
03107508
Device description
TMPL F/2.7/3.5 VA-LCP XARTICLR PROX ULNA PL 8H/LT/157MM
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120717000SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)Synthes USA2012-05-08HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819526464Direct MarkingGS10
10886982071491PrimaryGS10
H679031075080SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819526464076118195264647611819526464
1088698207149110886982071491

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. 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
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
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
08809986482594CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-23
00810112599275TriLEAPSynthes GmbHHRS2025-03-20
00810112599169TriLEAPSynthes GmbHHRS2025-03-18
00810112599176TriLEAPSynthes GmbHHRS2025-03-17
00810112599183TriLEAPSynthes GmbHHRS2025-03-17
00810112599190TriLEAPSynthes GmbHHRS2025-03-17
00810112599206TriLEAPSynthes GmbHHRS2025-03-17
00810112599213TriLEAPSynthes GmbHHRS2025-03-17
00810112599220TriLEAPSynthes GmbHHRS2025-03-17
00810112599237TriLEAPSynthes GmbHHRS2025-03-17
00810112599244TriLEAPSynthes GmbHHRS2025-03-17
00810112599251TriLEAPSynthes GmbHHRS2025-03-17
00810112599268TriLEAPSynthes GmbHHRS2025-03-17
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592450TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592467TriLeap Lower Etremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592474TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592634TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592832TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592986TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593006TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593013TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593020TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593037TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593044TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593051TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22