FDA.reportPublic FDA data

PROFEMUR®

Primary DI
M684PRNH00501
Brand
PROFEMUR®
Company
Microport Orthopedics Inc.
Model
PRNH0050
Catalog number
PRNH0050
Published
2016-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HYAFORCEPS, WIRE HOLDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYAForceps, Wire HoldingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M684PRNH00501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)872-0211Stephen.Weaver@ortho.microport.com

Regulatory Flags#

DUNS number
079118736
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
00192629005419ADVANCE®KPONTP26KPONTP262026-09-18
00192629005426ADVANCE®KPONTP29KPONTP292026-09-18
00192629005433ADVANCE®KPONTP32KPONTP322026-09-18
00192629005440ADVANCE®KPONTP35KPONTP352026-09-18
00192629005457ADVANCE®KPONTP38KPONTP382026-09-18
00192629005464ADVANCE®KPONTP41KPONTP412026-09-18
00192629005488ADVANCE®KPON32STKPON32ST2026-09-18
00192629005495ADVANCE®KPON35STKPON35ST2026-09-18
00192629005501ADVANCEKPON38SPKPON38SP2026-09-18
00192629005518ADVANCEKPON41SPKPON41SP2026-09-18
00192629005549ADVANCE®KPRC25HIKPRC25HI2026-09-18
00192629005556ADVANCE®KPRC25LOKPRC25LO2026-09-18
00192629005563ADVANCE®KPRC28HIKPRC28HI2026-09-18
00192629005570ADVANCE®KPRC28LOKPRC28LO2026-09-18
00192629082854EVOLUTIONETPKN1SLETPKN1SL2026-09-18
00192629082861EVOLUTIONETPKN2SLETPKN2SL2026-09-18
00192629082878EVOLUTIONETPKN2PLETPKN2PL2026-09-18
00192629082885EVOLUTIONETPKN3SLETPKN3SL2026-09-18
00192629082892EVOLUTIONETPKN4SLETPKN4SL2026-09-18
00192629082908EVOLUTIONETPKN5SLETPKN5SL2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250603753094LAZICPeter Lazic GmbHHYA2026-03-25
04250603753100LAZICPeter Lazic GmbHHYA2026-03-25
00194613028886MSI Precision Specialty InstrumentsMed Saver, Inc.HYA2025-08-01
03760225714096In2BonesIN2BONESHYA2024-12-13
04250603748526LAZICPeter Lazic GmbHHYA2024-11-20
04250603749295LAZICPeter Lazic GmbHHYA2024-11-20
03700569626877Newclip InstrumentsNEWCLIP TECHNICSHYA2024-11-08
03700569626884Newclip InstrumentsNEWCLIP TECHNICSHYA2024-11-08
04049197473248RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHYA2024-09-20
04049197473255RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHYA2024-09-20
00840183516758BR Surgical, LLCBR Surgical, LLCHYA2024-06-03
00840180519301General InstrumentsALPHATEC SPINE, INC.HYA2023-09-22
07898506853717QuinelatoSchobell Industrial LtdaHYA2023-07-07
07898506848676QuinelatoSchobell Industrial LtdaHYA2023-07-05
07898506814312QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853601QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853618QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853625QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853649QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853724QuinelatoSchobell Industrial LtdaHYA2022-12-16
07899798203310SchobellSchobell Industrial LtdaHYA2022-11-28
00840180508336General InstrumentsALPHATEC SPINE, INC.HYA2022-10-13
00887482055410Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HYA2022-08-25
00850027837642StabilICEACUTUS MEDICAL, INC.HYA2022-04-01
00850027837659StabilICEACUTUS MEDICAL, INC.HYA2022-04-01
04250603736608LAZICPeter Lazic GmbHHYA2021-12-22
04250603739487LAZICPeter Lazic GmbHHYA2021-12-22
00850027837529StabilICEACUTUS MEDICAL, INC.HYA2021-10-28
04250603736103LAZICPeter Lazic GmbHHYA2021-07-02
04250603736110LAZICPeter Lazic GmbHHYA2021-07-02