Kyphon® Osteo Introducer® System and BFD

GUDID 00763000557683

IBT KIT KPX103RB-A FF X2 10/3 OIS

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit
Primary Device ID00763000557683
NIH Device Record Keyc3f8befb-d787-458e-b0a3-d16ad938c3b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameKyphon® Osteo Introducer® System and BFD
Version Model NumberKPX103RB-A
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000557683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-17
Device Publish Date2021-08-09

On-Brand Devices [Kyphon® Osteo Introducer® System and BFD]

00763000557744IBT KIT KPX203RB-A FF X2 20/3 OIS
00763000557713IBT KIT KPX153RB-A FF X2 15/3 OIS
00763000557683IBT KIT KPX103RB-A FF X2 10/3 OIS

Trademark Results [Kyphon]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KYPHON
KYPHON
77920581 3837842 Dead/Cancelled
Kyphon SARL
2010-01-26
KYPHON
KYPHON
77145293 3380538 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
2007-03-30
KYPHON
KYPHON
77145286 3380537 Dead/Cancelled
MEDTRONIC HOLDING COMPANY SARL
2007-03-30
KYPHON
KYPHON
76124590 2509449 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
2000-09-07
KYPHON
KYPHON
75792575 2436526 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
1999-09-03

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