FDA.reportPublic FDA data

Mendec® Kypho Set Monolateral 20 mm

Primary DI
08031497003702
Brand
Mendec® Kypho Set Monolateral 20 mm
Company
TECRES SPA
Model
ASB030C
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
08031497003702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031497003702080314970037028031497003702

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
28031497000101Mendec Spine12302015-10-06
08031497003894InterSpace Hip Trial, 46mm ShortIHT46S2026-02-11
08031497003900InterSpace Hip Trial, 54mm ShortIHT54S2026-02-11
08031497003917InterSpace Hip Trial, 60mm ShortIHT60S2026-02-11
08031497003924InterSpace Hip Trial, 46mm Long IHT46L2026-02-11
08031497003931InterSpace Hip Trial, 54mm LongIHT54L2026-02-11
08031497003948InterSpace Hip Trial, 60mm LongIHT60L2026-02-11
08031497003955Interspace GV Hip Spacer 46IHGV46S2026-02-11
08031497003962Interspace GV Hip Spacer 54IHGV54S2026-02-11
08031497003979Interspace GV Hip Spacer 60IHGV60S2026-02-11
08031497003986Interspace GV Hip Spacer 46 XLIHGV46L2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLIHGV54L2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLIHGV60L2026-02-11
08031497002347InterSpace Knee TrialSPK90Z12022-09-23
08031497002897InterSpace Knee ATS Trial KitSPK90Z22022-09-23
08031497002903InterSpace Knee Trial XLSPK03Z12022-09-23
08031497003689Mendec® Kypho Set Monolateral 10 mmASB030A2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmASB030B2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmASB032A2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmASB032B2025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810141040892Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040908Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040915Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040953Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040977Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047532Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047549Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00840314270351gSourceGSOURCE LLCLXH2026-10-22
00840606175234PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606185820PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186506LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186513LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186575SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186612SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186643SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186674SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186704SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186735SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186810SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187091ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187121PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187640OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189934OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189941OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00190776436766MillenniumAvalign Technologies, Inc.LXH2026-10-21
07630699705240Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705257Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705264Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705271Surgical Manual InstrumentMedacta International SALXH2026-10-21
10840642132786Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-21