FDA.reportPublic FDA data

Mendec® Kypho Set Bilateral 20 mm

Primary DI
08031497003825
Brand
Mendec® Kypho Set Bilateral 20 mm
Company
TECRES SPA
Model
ASB032C
Device description
The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intended to provide the end user with either a monolateral or bilateral configuration for use in kyphoplasty procedures.
Published
2025-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope
HXGTamp
KIHDispenser, Cement
LXHOrthopedic Manual Surgical Instrument
OARInjector, Vertebroplasty (Does Not Contain Cement)
OCJSpinal Channeling Instrument, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
HXGTampOrthopedic1
KIHDispenser, CementOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1
OCJSpinal Channeling Instrument, VertebroplastyOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08031497003825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031497003825080314970038258031497003825

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement preparation/delivery kitA collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435428396
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
080314970020572Mix GunASA03102024-02-12
08031497002187GUN-01GUN-012022-09-23
08031497002330RALLY All In One Cement Gun712716102022-09-23
08031497002675Cemex System ContainerASA00302022-09-23
08031497002538Kyphon VuE™ Bone CementCT01A2022-05-13
08031497002095Conflow Bone Cement1100430252021-06-09
08031497002101Conflow G Bone Cement1100430262021-06-09
08031497002118MectaCem-X LV65.01.1032021-06-09
08031497002125MectaCem-X HV65.01.1012021-06-09
08031497002149MectaCem-X LV with Gentamicin65.01.113US2021-06-09
08031497002163MectaCem-X HV with Gentamicin65.01.111US2021-06-09
28031497000019Cemex RX1200/A2015-10-08
28031497000033CEMEX ISOPLASTIC1200/I2015-10-08
28031497000057CEMEX XL1200/S2015-10-08
28031497000071CEMEX ISOPLASTIC 1/2 PACK1220/I2015-10-08
28031497000101Mendec Spine12302015-10-06
28031497000491Cemex Genta LV1400/AG US2015-10-06
28031497000507Cemex Genta HV1400/IG US2015-10-06
08031497003894InterSpace Hip Trial, 46mm ShortIHT46S2026-02-11
08031497003900InterSpace Hip Trial, 54mm ShortIHT54S2026-02-11

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00842078123584KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
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00842078124215Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129609KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129616KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129623KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
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00842078129777IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129784IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
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