FDA.reportPublic FDA data

3P Hip System

Primary DI
00841132186374
Brand
3P Hip System
Company
ORTHOPEDIATRICS CORP.
Model
01-3000-0954
Catalog number
01-3000-0954
Device description
Triangular Positioning Plate 90°/50°/40°
Published
2025-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTHPROTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTHProtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132186374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132186374008411321863748411321863740841132186374

GMDN Terms#

Term, Definition table
TermDefinition
Bone-angle protractorA device intended to be used to measure the angles of bones, e.g., on x-rays or during surgery. It is commonly known as a protractor. This is a reusable 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
00840536822741Response 5.5/6.001-1300-653501-1300-65352026-05-30
00840536822758Response 5.5/6.001-1300-653601-1300-65362026-05-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008411321863813P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
008411321863983P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
008411321874943P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
08800017285429BENCOX DA Instruments Hip SystemCorentec Co., LtdHTH2024-01-29
G223WRROGPRO0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHTH2022-12-05
00614950025503ACEACE SURGICAL SUPPLY CO., INC.HTH2019-10-24
00842430108891ScoliometerMIZUHO ORTHOPEDIC SYSTEMS, INC.HTH2019-04-02
00889024038004NAZimmer, Inc.HTH2016-07-27