Navigated NIM-SPINE®

GUDID 00643169555495

PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT

MEDTRONIC NAVIGATION, INC.

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Primary Device ID00643169555495
NIH Device Record Key74117b51-d21b-47d4-946a-462ba1d92aa6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavigated NIM-SPINE®
Version Model Number9733497
Company DUNS835233107
Company NameMEDTRONIC NAVIGATION, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169555495 [Primary]
GS100643169555495 [Primary]
GS100643169555495 [Primary]
GS100643169555495 [Primary]
GS100643169555495 [Primary]
GS100643169555495 [Primary]
GS100643169555495 [Primary]
GS100643169555495 [Primary]

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar
MAXIntervertebral fusion device with bone graft, lumbar
MAXIntervertebral fusion device with bone graft, lumbar
MAXIntervertebral fusion device with bone graft, lumbar
MAXIntervertebral fusion device with bone graft, lumbar
MAXIntervertebral fusion device with bone graft, lumbar
MAXIntervertebral fusion device with bone graft, lumbar
MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-31

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

00643169555495 - Navigated NIM-SPINE®2020-11-09PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
00643169555495 - Navigated NIM-SPINE®2020-11-09 PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
00643169946538 - N/A2020-11-09 STEALTH 9735894 S8 PLANNING STATION
00643169966963 - N/A2020-11-09 INTF KIT 9736023 ZEISS PENTERO HUD S8
00763000280871 - Monopolar2020-11-02 MONO SEALING HOOK 13-201-1 ENDO SH2.0
00763000280857 - Monopolar2020-10-26 MONO SEALER 13-101-1 DISSECTING DS3.0
00763000336592 - N/A2020-10-26 COMPUTER 9736242 AIO FLEX ENT
00763000355555 - O-ARM®2020-10-26 O-ARM SYS BI70002000 O2 UE 120V B EN UEN
00763000416805 - StealthAiR™ Spine2020-10-26 SFW KIT 9736350 STEALTH AIR

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