FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00643169047907
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
5584255
Device description
BENDER 5584255 5.5/6.0 IN-SITU LEFT
Published
2022-11-26
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
HXPINSTRUMENT, BENDING OR CONTOURING
HXWBENDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXPInstrument, Bending Or ContouringOrthopedic1
HXWBenderOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169047907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169047907006431690479076431690479070643169047907

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800089476886Surgical InstrumentJeil Medical CorporationHXW2026-04-09
08800089476893Surgical InstrumentJeil Medical CorporationHXW2026-04-09
07640332475553CURE 2.0 ACPSpineArt SAHXW2025-11-12
07640375234834PERLA ® TLSpineArt SAHXW2025-11-10
07640375234841PERLA ® TLSpineArt SAHXW2025-11-10
07640375234858PERLA ® TLSpineArt SAHXW2025-11-10
07640375234865PERLA ® TLSpineArt SAHXW2025-11-10
10705034576985N/ADEPUY SPINE, LLCHXW2024-12-16
07640187461572Bending IronBonebridge AGHXP2022-12-23
G079C5040000010Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
G079C5040000020Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
G079C5040000030Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
08800089415212INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089417308INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089418268INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089402755Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHXW2021-05-28
10884389956212MedlineMEDLINE INDUSTRIES, INC.HXW2020-08-21
10705034548470NADEPUY SPINE, LLCHXW2019-02-20
10705034534985NADEPUY SPINE, LLCHXW2019-02-12
10705034535722NADEPUY SPINE, LLCHXW2019-02-12
07640178989474ROMEO 2 INSTRUMENTATIONSpineArt SAHXW2019-01-31
07640178989481ROMEO 2 INSTRUMENTATIONSpineArt SAHXW2019-01-31
08806390872010VERUM System Surgical InstrumentJeil Medical CorporationHXW2018-12-17
08806390863261Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHXW2018-12-05
08806390867337Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHXW2018-12-05
08806390800211Surgical InstrumentJeil Medical CorporationHXW2018-11-28
08806390801317Surgical InstrumentJeil Medical CorporationHXW2018-11-28
08806390859806VERUM System Surgical InstrumentJeil Medical CorporationHXW2018-11-28
08806390860109VERUM System Surgical InstrumentJeil Medical CorporationHXW2018-11-28
08806390869065Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHXW2018-11-28