FDA.reportPublic FDA data

KYPHON Express II KyphoPak Tray

Primary DI
00763000026905
Brand
KYPHON Express II KyphoPak Tray
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
KEX102NB
Device description
BONE TAMP KIT KEX102NB AF E2 10/2
Published
2019-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope
HRZProsthesis, knee, hinged (metal-metal)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
HRZProsthesis, Knee, Hinged (Metal-Metal)Orthopedic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123771000
K911729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123771000KYPHON EXPRESS II INFLATABLE BONE TAMPSMedtronic2012-12-21HRX
K911729000DANEKSCOPE AND ACCESSORIESDanek Medical, Inc.1993-04-05HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000026905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000026905007630000269057630000269050763000026905

GMDN Terms#

Term, Definition table
TermDefinition
Balloon kyphoplasty kitA collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool (at max. 25°C / 77°F), dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Kit
true
Lot or batch
true

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Primary DI, Brand, Model table
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00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24

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