FDA.reportPublic FDA data

Medtronic Resuable Instruments

Primary DI
00643169984660
Brand
Medtronic Resuable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0217050
Device description
CURTTE X0217050 5.2MM LFT OFST FRWD ANGL
Published
2022-11-13
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
HTFCURETTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169984660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169984660006431699846606431699846600643169984660

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00199150082810Medtronic Reusable InstrumentsX02260262026-07-04
00199150082827Medtronic Reusable InstrumentsX02260272026-07-04
00199150082834Medtronic Reusable InstrumentsX02260282026-07-04
00199150082841Medtronic Reusable InstrumentsX02260292026-07-04
00199150082858Medtronic Reusable InstrumentsX02260302026-07-04
00199150082865Medtronic Reusable InstrumentsX02260312026-07-04
00199150082872Medtronic Reusable InstrumentsX02260322026-07-04
00199150082889Medtronic Reusable InstrumentsX02260332026-07-04
00199150082896Medtronic Reusable InstrumentsX02260342026-07-04
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00763000875176MSB SHILLA Growth Guidance System76755352026-07-04
00643169101296MSB VERTEX® Reconstruction SystemG77538052026-06-27
00643169465879MSB CD HORIZON Spinal SystemX10131802026-06-28
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy System43612052026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy System4361203002026-06-26
00643169190542CLYDESDALE PTC™ Spinal System49868402016-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190464NAPACIFIC INSTRUMENTS, INC.HTF2026-07-06
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B803PS00991080ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099108A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991090ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099109A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991100ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099110A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395900ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS03959000ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS039590000ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395910ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395920ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395930ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395950ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395960ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0595940ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991010ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099101A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991020ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099102A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991030ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099103A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991040ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099104A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991050ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099105A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991060ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099106A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991070ORTHOMEDORTHO-MED, INC.HTF2026-06-25