FDA.report

N/A

Primary DI
00643169731448
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0216053
Device description
CURETTE X0216053 8MM RING LEFT HANDED
Published
2017-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTFCURETTE

Product Code Classifications

CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00643169731448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169731448006431697314486431697314480643169731448

GMDN Terms

TermDefinition
Bone graft funnelA device designed to deliver bone graft filling material (autologous, allogeneic, xenogeneic, or synthetic) during an orthopaedic procedure to enable the filling of bone gaps intended to be fused. It is a funnel-shaped device; the funnel being bowl-shaped with the ability to hold back the filling material depending upon the angle of tilt applied by the surgeon, and a long, thin tube that can be inserted into the site to be filled, e.g., a cancellous bone graft being discharged into the posterior disc space of a vertebra. An orthopaedic graft inserter can be pushed down the funnel tube to press the graft material into the site. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
830350380
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24
00199150071814Medtronic Reusable InstrumentsEX02261002026-05-24
00199150072057Medtronic Reusable InstrumentsX65500232026-05-23
00199150072064Medtronic Reusable InstrumentsX65500242026-05-23
00199150072576Medtronic Reusable InstrumentsEX02260222026-05-23
00199150074532Medtronic Reusable InstrumentsX12250022026-05-22
00199150074549Medtronic Reusable InstrumentsX12250032026-05-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
24026704941692PILLINGTELEFLEX INCORPORATEDHTF2026-03-23
24026704941708PILLINGTELEFLEX INCORPORATEDHTF2026-03-23
00192896122871Spoon CuretteSONTEC INSTRUMENTS, INC.HTF2026-03-19
00810158219052PRINCETONPrinceton Medical Group, Inc.HTF2026-03-11
00190776393229MillenniumAvalign Technologies, Inc.HTF2026-03-04
00810168190297NAPACIFIC INSTRUMENTS, INC.HTF2026-03-03
00190776417260MillenniumAvalign Technologies, Inc.HTF2026-02-20
00190776416447MillenniumAvalign Technologies, Inc.HTF2026-02-16
00190776416669MillenniumAvalign Technologies, Inc.HTF2026-02-16
03662663109475Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109512Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109529Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109543Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109550Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109567Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
00190776416010MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416027MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416041MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416058MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416065MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776415785MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415792MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415808MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415815MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415822MillenniumAvalign Technologies, Inc.HTF2026-02-04
03662663083584ActivLHighridge Medical, LLCHTF2026-02-03
03662663083591ActivLHighridge Medical, LLCHTF2026-02-03
03662663083607ActivLHighridge Medical, LLCHTF2026-02-03
03662663083614ActivLHighridge Medical, LLCHTF2026-02-03
03662663083621ActivLHighridge Medical, LLCHTF2026-02-03