FDA.reportPublic FDA data

3P Hip System

Primary DI
00840194472913
Brand
3P Hip System
Company
ORTHOPEDIATRICS CORP.
Model
00-3001-3963
Catalog number
00-3001-3963
Device description
90° Adolescent Offset Plate, 3-Hole, 6mm Offset
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
HRSPlate, fixation, bone

Product Code Classifications#

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

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
00840194472913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194472913008401944729138401944729130840194472913

GMDN Terms#

Term, Definition table
TermDefinition
Femoral neck fixation plate/sleeveAn implantable, non-bioabsorbable, non-customized sheet of firm material that incorporates a sleeve (commonly known as a barrel) at its proximal end designed to be attached with screws to the proximal femur to treat a femoral neck (trochanteric) fracture. The sleeve is intended to be introduced into the bone to hold a sliding screw (commonly known as a lag or dynamic screw) and/or a deployable-hook pin [not included] that is implanted into the femoral head/neck to compress the fracture. It is available in various sleeve angles/sizes. Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., cortical bone screws), may be included with the plate/sleeve.

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
00841132133200PediFlex01-1000-00101-1000-0012017-02-15
00841132133217PediFlex01-1000-00201-1000-0022017-02-15
00841132135280PediNail21-1500-00721-1500-0072017-02-15
00841132135297PediNail21-1500-01021-1500-0102017-02-15
00841132135303PediNail21-1500-01221-1500-0122017-02-15
00841132135310PediNail21-1500-01321-1500-0132017-02-15
00841132135334PediNail21-1500-01921-1500-0192017-02-15
00841132135341PediNail21-1500-11221-1500-1122017-02-15
00841132135358PediNail21-1500-11921-1500-1192017-02-15
00841132135372PediNail21-1500-911321-1500-91132017-02-15
00841132135389PediNail21-1500-921321-1500-92132017-02-15
00841132135396PediNail21-1500-921421-1500-92142017-02-15
00841132179833Vilex ToolP460-45-100P460-45-1002020-03-02
00841132179888Orthex ToolPP460-15-110PP460-15-1102020-03-02
00841132142325eZ-Fix500-G500-G2020-02-28
00841132142905eZ-Fix900-CW-14900-CW-142020-02-28
00841132142950eZ-Fix900-TW-30900-TW-302020-02-28
00841132143025eZ-Fix925-TW-30925-TW-302020-02-28
00841132125014General Instrument01-1003-300101-1003-30012016-09-25
00841132125021General Instrument01-1003-300201-1003-30022016-09-25

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