KYPHON® Express™ II Inflatable Bone Tamp

GUDID 00763000312015

BONE TAMP KE102 10/2 EXPRESS II IBT

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp
Primary Device ID00763000312015
NIH Device Record Keyd1fea627-f431-44d4-84e9-765e611875d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameKYPHON® Express™ II Inflatable Bone Tamp
Version Model NumberKE102
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
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 Perscriptionfalse
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
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 (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000312015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HXGTAMP

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-05
Device Publish Date2020-09-25

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00673978050621 - n/a2025-07-25 INSTRUMENT 836-036 HOLT PROBE CURVED
00199150021543 - Medtronic Reusable Instruments2025-07-21 HOLDER X0625020 BONE GRAFT
00199150021550 - Medtronic Reusable Instruments2025-07-21 SLAP HAMMER X0625025 BONE GRAFT HOLDER
00763000703578 - Medtronic Reusable Instruments2025-07-21 CAM SPREADER TRIAL 4000017 6 DEG 17MM
00763000703592 - Medtronic Reusable Instruments2025-07-21 CAM SPREADER TRIAL 4010010 12 DEG 10MM
00763000703608 - Medtronic Reusable Instruments2025-07-21 CAM SPREADER TRIAL 4010011 12 DEG 11MM
00763000703615 - Medtronic Reusable Instruments2025-07-21 CAM SPREADER TRIAL 4010012 12 DEG 12MM
00763000703622 - Medtronic Reusable Instruments2025-07-21 CAM SPREADER TRIAL 4010013 12 DEG 13MM

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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