FDA.reportPublic FDA data

3P Hip System

Primary DI
00841132186145
Brand
3P Hip System
Company
ORTHOPEDIATRICS CORP.
Model
01-3002-3099
Catalog number
01-3002-3099
Device description
3P Adolescent Beam - Trephine
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
GFGBIT, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132186145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132186145008411321861458411321861450841132186145

GMDN Terms#

Term, Definition table
TermDefinition
Bone trephine, single-useAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. 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
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
00843193102447Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102454Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102461Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102478Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102485Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102492Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102508Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102515Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193115706Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193115713Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00860016074101CARTISTEM® Subchondral Bone Drill Bit - 4mmMedipost, Inc.GFG2026-07-28
008405368002063P Hip SystemORTHOPEDIATRICS CORP.GFG2026-06-12
008405368002133P Hip SystemORTHOPEDIATRICS CORP.GFG2026-06-12
008405368002203P Hip SystemORTHOPEDIATRICS CORP.GFG2026-06-12
00811714036540ThunderboltRESPONSIVE ORTHOPEDICS LLCGFG2025-05-14
00811714036557ThunderboltRESPONSIVE ORTHOPEDICS LLCGFG2025-05-14
10888277326200MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
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10888277378261MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
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