FDA.reportPublic FDA data

Femoral Cement Pressuriser

Primary DI
15060238201596
Brand
Femoral Cement Pressuriser
Company
SUMMIT MEDICAL LIMITED
Model
P721
Catalog number
P721
Device description
Femoral Cement Pressuriser
Published
2025-01-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWNInstrument, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25060238201593PackageGS110In Commercial Distribution
15060238201596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2506023820159325060238201593
1506023820159615060238201596

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+441451821311info@summit-medical.co.uk

Regulatory Flags#

DUNS number
221751311
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060238201923Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18
25060238201920Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18
15060238201138CellTrans ABT45102018-12-21
15060238201329Spatula & Curette PackSC012022-08-23
15060238201633HiVac™ 7 Triple Mix C703C7032025-01-10
15060238201657HiVac™ 7 with Femoral Cement Pressuriser CP701CP7012025-01-10
15060238201671HiVac™ SyringeS727S7272025-01-10
15060238201688HiVac™ SyringeS717WS717W2025-01-10
150602382017189mm Nozzle With Nozzle ExtruderN700N7002025-01-10
15060238201725Quick-Vac® Vacuum Mixing Bowl00504900100005049001002025-01-10
15060238201732Quick-Vac® Vacuum Mixing Bowl00504900115005049001152025-01-10
15060238201749HiVac BowlB713B7132025-01-10
15060238201756Rally™ Vacuum Mixing Bowl7127-18017127-18012025-01-10
15060238201770Cement Mixing and Delivery System00-4501-090-0000-4501-090-002025-01-10
15060238201787 MiniMix™SMMM1SMMM12025-01-10
15060238201794MiniMix™ LVSMLVSMLV2025-01-10
15060238201800MiniMix™ Delivery SyringeSMDS1CSMDS1C2025-01-10
15060238201886Mixing bowl, SpatulaB710B7102025-01-10
25060238201593Femoral Cement PressuriserP721P7212025-01-10
25060238201630HiVac™ 7 Triple Mix C703C7032025-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840311262953Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-27
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWN2026-03-30
00840311245451Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-03-18
00810111226691Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-02-20
00818345029774RIVA Posterior Fixation SystemXENIX MEDICAL LLCHWN2026-01-12
00810111226677Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00810111226684Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00810111226707Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00840298704637Songer® Spinal Cable SystemPioneer Surgical Technology, Inc.HWN2024-08-23
00643169350991Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWN2022-10-08
G079C5060000010Golden Isles Pedicle Screw SystemIntelivation, LLCHWN2022-09-23
00613994878137n/aMEDTRONIC SOFAMOR DANEK, INC.HWN2022-08-06
00721902875755N/AMEDTRONIC SOFAMOR DANEK, INC.HWN2022-08-06
20886982313437NASynthes GmbHHWN2022-07-29
20886982313444NASynthes GmbHHWN2022-07-29
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20886982313512NASynthes GmbHHWN2022-07-29
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20886982313536NASynthes GmbHHWN2022-07-29
20886982313543NASynthes GmbHHWN2022-07-29