FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00763000253653
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX0219052
Device description
COBB EX0219052 6MM DISTRACTOR
Published
2022-10-14
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
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY
HTEELEVATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000253653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000253653007630002536537630002536530763000253653

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
00643169839397INFINITY™ Occipitocervical Upper Thoracic System36070052018-06-10
00199150082780Medtronic Reusable InstrumentsX02260232026-07-04
00199150082797Medtronic Reusable InstrumentsX02260242026-07-04
00199150082803Medtronic Reusable InstrumentsX02260252026-07-04
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
00763000873714MSB SHILLA Growth Guidance System76750252026-07-04
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
B382SD9147091800Surgical DirectSurgical Direct, Inc.GEG2026-07-09
00850083275822Intrace USAPILOTIS TECH LLCGEG2026-07-03
00850083275853Intrace USAPILOTIS TECH LLCGEG2026-07-03
10705034579580N/AMedos International SàrlHTE2026-06-25
10705034579597N/AMedos International SàrlHTE2026-06-25
10705034579603N/AMedos International SàrlHTE2026-06-25
B8039702640ORTHOMEDORTHO-MED, INC.HTE2026-06-22
008401944957383P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GEG2026-06-10
008405368002753P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GEG2026-06-10
00846338005467FreerELLIQUENCE, LLCGEG2026-06-01
G383S1061WM8535437SURJEXSURJEXGEG2026-05-31
G4251902480My MedicalMy Medical Store LLCGEG2026-05-04
09348811078988INKAThe Trustee for KAISER FAMILY TRUSTHTE2026-03-18
07898506841370QuinelatoSchobell Industrial LtdaHTE2023-01-10
07898506841356QuinelatoSchobell Industrial LtdaHTE2022-12-16
07898506841363QuinelatoSchobell Industrial LtdaHTE2022-12-16
B382SD921353210Surgical DirectSurgical Direct, Inc.GEG2022-12-01
B382SD9213541000Surgical DirectSurgical Direct, Inc.GEG2022-12-01
10381780423997Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780424116Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780445517Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780407706Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-03
10381780408468Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-05-03
10381780408475Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-05-03
10381780401254Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401254Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-05-02
10381780401261Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-05-02
10381780401261Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401278Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401278Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-05-02