N/A

GUDID 00643169241916

CAGE 2561232 LOOP 12MM X 32.5MM 6DEG

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00643169241916
• NIH Device Record Key: 902d5fce-fc1d-4c24-b0e0-b3c8940a154c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 2561232
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 32.5 Millimeter
• Length: 32.5 Millimeter
• Length: 32.5 Millimeter
• Length: 32.5 Millimeter
• Length: 32.5 Millimeter
• Length: 32.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169241916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121332

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-07-01

On-Brand Devices [N/A]

• 00613994949042: TRAY 7069005 DUAL LEAD TAP
• 00613994946720: ROCKER 5484333 ROCKER EXTENDED
• 00613994946706: LID 7068567 CANN MAS XTRA 5.5-8.5 LID
• 00613994946690: MODULE 7068566 CANN MAS XTRA 5.5-8.5 MOD
• 00613994946683: LID 7068565 CANN MAS EXTRA 7.5 MOD LID
• 00613994946676: MODULE 7068564 CANN MAS EXTRA 7.5 MOD
• 00613994946652: DRIVER 5484339 DUAL PURPOSE DRIVER
• 00613994946638: PROTECTOR 2942058 18MM ENDPLATE
• 00613994946614: STARTER 5484338 NON-BREAKOFF PLUG
• 00613994946607: DRIVER 5484337 NON-BRKOFF PROVSNL INSERT
• 00613994946591: DRIVER 5484336 RMAS BREAKOFF
• 00613994946515: IMPLANT HOLDER EX0111192 5.5 STRAIGHT
• 00613994944931: ROD GRIPPER X0111149 90 DEGREE
• 00613994937841: MODIFIED X0110242 FLEX ARM
• 00613994922274: IMPLANT HOLDER EX1210012 6.35 STRAIGHT
• 00613994922182: REDUCER EX0810522 MICRO
• 00613994912046: INSTRUMENT 7570946 SCREW GHOST
• 00613994912039: INSTRUMENT 7570945 FLUOROSCOPIC RULER
• 00613994912022: INSTRUMENT 7570944 EXTENDER COLLAR
• 00613994912015: INSTRUMENT 7570942 FRACTURE REDUCER
• 00613994912008: INSTRUMENT 7570940 COMPRESSOR DISTRACTOR
• 00613994909817: 9.5 TAP X1010056 CANNULATED DUAL THREAD
• 00613994909800: 9.0 TAP X1010055 CANNULATED DUAL THREAD
• 00613994909794: 8.5 TAP X1010022 CANNULATED DUAL THREAD
• 00613994905758: ADAPTER 2346051 POWEREASE HANDLE ADAPTER
• 00613994905741: ADAPTER 2346050 POWEREASE SQUARE ADAPTER
• 00613994904850: GUIDEWIRE X1110004 BLUNT
• 00613994901170: TRAY 1207788 PREVAIL
• 00613994901163: HOLDER 5484391 4.75 VCM IMPLANT HOLDER
• 00613994901057: RETRACTOR X0810464 RACK WORM GEAR
• 00613994898043: TRAY 6660010 STND TRIAL LOWER
• 00613994896384: CRIMP X1010599 MINI REDUCTION
• 00613994896377: REMOVAL TOOL X1010604 MINI CRIMP
• 00613994894953: SPECULUM X0810494 70MM
• 00613994894946: SPECULUM X0810493 50MM
• 00613994894939: SPECULUM X0810492 30MM
• 00613994894779: DRILL X1010147 2.4MM BIT
• 00613994894755: TAP X09103869 CANNULATED 4.5
• 00613994894748: TAP X09103870 CANNULATED 5.0
• 00613994894731: TAP X09103871 CANNULATED 5.5
• 00613994894724: TAP X09103872 CANNULATED 6.0
• 00613994894717: TAP X09103873 CANNULATED 6.5
• 00613994894700: TAP X09103874 CANNULATED 7.0
• 00613994894694: TAP X09103875 CANNULATED 7.5
• 00613994894687: TAP X09103876 CANNULATED 8.0
• 00613994894670: TAP X09103877 CANNULATED 8.5
• 00613994894663: TAP X09103878 CANNULATED 9.0
• 00613994894656: TAP X09103879 CANNULATED 9.5
• 00613994888372: TRAY 9396009 INSTTRAY3
• 00613994884657: PIN X09103370 PLATE HOLDING EXTENDED