FDA.reportPublic FDA data

3P Hip System

Primary DI
00841132186329
Brand
3P Hip System
Company
ORTHOPEDIATRICS CORP.
Model
01-3000-0009
Catalog number
01-3000-0009
Device description
1.8mm x 200mm Smooth Guide Wire
Published
2025-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIJInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132186329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132186329008411321863298411321863290841132186329

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, single-useA thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840536822543Prone Perfect03-1300-880103-1300-88012026-05-22
00840536822550Prone Perfect03-1300-880203-1300-88022026-05-22
00840536822567Prone Perfect03-1300-880303-1300-88032026-05-22
00840536822574Prone Perfect03-1300-880403-1300-88042026-05-22
00840536822581Prone Perfect03-1300-880503-1300-88052026-05-22
00840536822598Prone Perfect03-1300-880603-1300-88062026-05-22
00840536822604Prone Perfect03-1300-880703-1300-88072026-05-22
00840536822611Prone Perfect03-1300-880803-1300-88082026-05-22
00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
00840536822635Prone Perfect03-1300-881003-1300-88102026-05-22
00840536822642Prone Perfect03-1300-881103-1300-88112026-05-22
00841132199244OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6000-S00-1200-6000-S2026-05-13
00841132199251OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6001-S00-1200-6001-S2026-05-13
00841132199268OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6002-S00-1200-6002-S2026-05-13
00841132199275OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6003-S00-1200-6003-S2026-05-13
00841132199282OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6004-S00-1200-6004-S2026-05-13
00841132199299OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6005-S00-1200-6005-S2026-05-13
00841132199305OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6006-S00-1200-6006-S2026-05-13
00841132199312OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6014-S00-1200-6014-S2026-05-13
00841132199329OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6015-S00-1200-6015-S2026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809260475649TRAUS SSG40Saeshin Precision Co., Ltd.KIJ2026-05-19
08800038060807EZImpactorIMEDICOM CO., LTD.KIJ2026-04-21
08800038060814EZImpactorIMEDICOM CO., LTD.KIJ2026-04-21
08809260473812TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473829TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473836TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473843TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473850TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473867TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473874TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473881TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473898TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473904TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473911TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260474598TRAUS SSG20Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475182TRAUS SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475526SSG20Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475533SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475540SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475557SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08800038060784EZImpactorIMEDICOM CO., LTD.KIJ2026-04-01
08800038060791EZImpactorIMEDICOM CO., LTD.KIJ2026-04-01
10603295559511INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
10603295559597INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
10603295559771INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
10603295559801INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
10603295559825INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
00840286841603Consensus Hip SystemShalby Advanced Technologies, Inc.KIJ2025-05-22
00840286841610Consensus Hip SystemShalby Advanced Technologies, Inc.KIJ2025-05-22
00840286841627Consensus Hip SystemShalby Advanced Technologies, Inc.KIJ2025-05-22