FDA.reportPublic FDA data

KyphPak® First Fracture Tray

Primary DI
00643169671782
Brand
KyphPak® First Fracture Tray
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
KPX153PB-CDS
Device description
KIT KPX153PB-CDS 15/3 FF 1-STEP WITH CDS
Published
2016-04-03
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
HXGTAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
HXGTampOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103231000KYPHON INFLATION SYRINGEMedtronic Spine, LLC2011-01-24HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169671782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169671782006431696717826431696717820643169671782

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 dry place (at max 25°C/77°F)

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

Other Devices From This Company#

Primary DI, Brand, Model table
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00763000881252Clydesdale™ Spinal System49860402026-05-29
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00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
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00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
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00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
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