FDA.reportPublic FDA data

3P Hip System

Primary DI
00840194472647
Brand
3P Hip System
Company
ORTHOPEDIATRICS CORP.
Model
00-3000-1000
Catalog number
00-3000-1000
Device description
Infant Connector Bolt
Published
2025-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDODEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDODevice, Fixation, Proximal Femoral, ImplantOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243963000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243963000Pediatric Plating Platform HipOrthoPediatrics Corp.2025-04-29HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194472647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194472647008401944726478401944726470840194472647

GMDN Terms#

Term, Definition table
TermDefinition
Implantable orthopaedic/craniofacial device connection screwA small implantable surgical device designed to join (connect) two components of an implanted orthopaedic and/or craniofacial device (e.g. osteotomy wedge to plate, femoral neck screw and plate); it is not intended to be screwed into the bone. It is typically made of metal and in the form of a short rod with machine threads at one end and a connecting slot (e.g., sunken Hex head) or thumbscrew at the other end.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379xxx@xxx.com

Regulatory Flags#

DUNS number
796416191
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841132177570OrthoPediatrics QuickPack Bone Void FillerOPQS1005OPQS10052020-02-11
00841132177587OrthoPediatrics QuickPack Bone Void FillerOPQS1008OPQS10082020-02-11
00841132177594OrthoPediatrics QuickPack Bone Void FillerOPQS1016OPQS10162020-02-11
00841132177600OrthoPediatrics QuickPack Bone Void FillerOPQS0004OPQS00042020-02-11
00840536824288PediHipNS-5001-1711NS-5001-17112026-10-07
00840536824295PediHipNS-5001-1712NS-5001-17122026-10-07
00840536824301PediHipNS-5001-1713NS-5001-17132026-10-07
00840536824318PediHipNS-5001-1714NS-5001-17142026-10-07
00840536824325PediHipNS-5001-1715NS-5001-17152026-10-07
00840536824332PediHipNS-5001-1716NS-5001-17162026-10-07
00840536824349PediHipNS-5001-1721NS-5001-17212026-10-07
00840536824356PediHipNS-5001-1722NS-5001-17222026-10-07
00840536824363PediHipNS-5001-1723NS-5001-17232026-10-07
00840536824370PediHipNS-5001-1724NS-5001-17242026-10-07
00840536824387PediHipNS-5001-1725NS-5001-17252026-10-07
00840536824394PediHipNS-5001-1726NS-5001-17262026-10-07
00817867021044PNP Femur00-1560-716000-1560-71602026-10-01
00817867021051PNP Femur00-1560-716500-1560-71652026-10-01
00817867021068PNP Femur00-1560-717000-1560-71702026-10-01
00817867021075PNP Femur00-1560-717500-1560-71752026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982174994DHSSynthes GmbHJDO2015-09-14
10886982175007DHSSynthes GmbHJDO2015-09-14
10886982175014DHSSynthes GmbHJDO2015-09-14
10886982175021DHSSynthes GmbHJDO2015-09-14
10886982175038DHSSynthes GmbHJDO2015-09-14
10886982175045DHSSynthes GmbHJDO2015-09-14
10886982175052DHSSynthes GmbHJDO2015-09-14
10886982175069DHSSynthes GmbHJDO2015-09-14
10886982175076DHSSynthes GmbHJDO2015-09-14
10886982175083DHSSynthes GmbHJDO2015-09-14
10886982175090DHSSynthes GmbHJDO2015-09-14
10886982175106DHSSynthes GmbHJDO2015-09-14
10886982175113DHSSynthes GmbHJDO2015-09-14
10886982175120DHSSynthes GmbHJDO2015-09-14
10886982175137DHSSynthes GmbHJDO2015-09-14
10886982175144DHSSynthes GmbHJDO2015-09-14
10886982175151DHSSynthes GmbHJDO2015-09-14
10886982175168DHSSynthes GmbHJDO2015-09-14
10886982175175DHSSynthes GmbHJDO2015-09-14
10886982175182DHSSynthes GmbHJDO2015-09-14
10886982175212DHSSynthes GmbHJDO2015-09-14
10886982175229DHSSynthes GmbHJDO2015-09-14
10886982175236DHSSynthes GmbHJDO2015-09-14
10886982175243DHSSynthes GmbHJDO2015-09-14
10886982175250DHSSynthes GmbHJDO2015-09-14
10886982175267DHSSynthes GmbHJDO2015-09-14
10886982175274DHSSynthes GmbHJDO2015-09-14
10886982175281DHSSynthes GmbHJDO2015-09-14
10886982175298DHSSynthes GmbHJDO2015-09-14
10886982175304DHSSynthes GmbHJDO2015-09-14