FDA.reportPublic FDA data

CEMENT PRESSURIZER

Primary DI
08031497002248
Brand
CEMENT PRESSURIZER
Company
TECRES SPA
Model
PRZ-01
Device description
Cement Pressurizer is intended to be used in cemented arthroplasty for the pressurization of the cement inside the femoral canal during retrograde filling.
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08031497002248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031497002248080314970022488031497002248

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement compressorA device used to apply pressure to orthopaedic bone cement during a total hip arthroplasty (THA) procedure (within the acetabulum and/or femur) in order to optimise inner bone (cancellous) cement interdigitation to improve fixation of the implant. The device is typically made of a compressible silicone rubber which conforms to the shape of the cut bone to enable formation of a good seal. Cement may be injected through the device into the bone cavity using an appropriate syringe; pressure may be applied to the device with a firm handle (e.g., stainless steel), or a backplate. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435428396
Device count
1
Premarket exempt
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
08031497003702Mendec® Kypho Set Monolateral 20 mmASB030C2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmASB032A2025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327697209PANGEAStryker GmbHLXH2026-08-27
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00840606185981ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185998ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186001ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186018ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186025ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186032ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186056ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186063ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186070ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186087ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186094ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186100ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186117ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186131ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186155ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186162ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186179ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186193ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186209ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186247ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186254ALIFSPINAL ELEMENTS, INC.LXH2026-08-26