FDA.reportPublic FDA data

Polarcup Impactor Interface Sz 61

Primary DI
09421028114981
Brand
Polarcup Impactor Interface Sz 61
Company
ENZTEC LIMITED
Model
351342512161
Catalog number
351342512161
Device description
A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
Published
2023-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWAImpactor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421028114981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421028114981094210281149819421028114981

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
592616445
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421038412220Enztec XR Trinket M8X1.0-014252-24494252-24492026-03-13
09421038412145Cup reamer handle, offset, Z/H, locking9209-13019209-13012026-03-09
09421038412152Offset coupling, Z/H9209-13069209-13062026-03-09
09421038412169Offset drive train, locking9209-13039209-13032026-03-09
09421038412176Short Offset Cover – United9209-13079209-13072026-03-09
09421038412183Handle – United9209-13059209-13052026-03-09
09421038412299Cup reamer handle, offset, AO, locking9209-13119209-13112026-03-09
09421038412305Offset coupling, AO9209-13139209-13132026-03-09
09421038412312Cup reamer handle, offset, AO, open9209-13129209-13122026-03-09
09421038412329Offset drive train, open9209-13049209-13042026-03-09
09421038412671Cup reamer handle, offset, Z/H, open9209-13029209-13022026-03-09
09421038411865Enztec Modular OCI X4251-31014251-31012026-02-27
09421038411889Adj Dist Fem Alignment Guide – Cartilage4240-77004240-77002026-02-27
09421038411896Adj Dist Fem Alignment Guide – Paddle4240-77014240-77012026-02-27
09421038411902Sagittal Alignment Connector - Pivot4240-77054240-77052026-02-27
09421038411919Sagittal Alignment Connector - Pivot with Fan4240-77064240-77062026-02-27
09421038411926Dist Fem Cut Block Connector – 8mm4240-77104240-77102026-02-27
09421038411933Dist Fem Cut Block Connector – 9mm4240-77114240-77112026-02-27
09421038411940Dist Fem Cut Block Connector – 10mm4240-77124240-77122026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mm4240-77254240-77252026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862648150EquinoxeExactech, Inc.HWA2026-03-19
09421038412220Enztec XR Trinket M8X1.0-01ENZTEC LIMITEDHWA2026-03-13
00840277133403Innomed, Inc.INNOMED, INC.HWA2026-03-11
00810123209934Adler Instrument CompanyAdler, Inc.HWA2026-03-03
05056405508578Charnley Femoral Prosthesis PusherPLATTS & NISBETT LIMITEDHWA2026-02-11
00822409133178N/AOrtho Development CorporationHWA2026-02-05
00822409133185N/AOrtho Development CorporationHWA2026-02-05
00822409133192N/AOrtho Development CorporationHWA2026-02-05
00822409133215N/AOrtho Development CorporationHWA2026-02-05
10603295554974EMPHASYSDEPUY ORTHOPAEDICS, INC.HWA2026-02-04
04026575048168General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2026-02-02
04026575080182General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2026-02-02
08800017299358BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887734BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887826BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887833BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373888021BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373888045BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
09421028112536Enztec Classic OCI - Trinket 5/16-24 UNF-02ENZTEC LIMITEDHWA2026-01-12
09421028113540Enztec Classic OCI - Trinket 3/8-16 UNC-01ENZTEC LIMITEDHWA2026-01-12
09421028113557Enztec Classic OCI - Trinket 5/16-24 UNF-01ENZTEC LIMITEDHWA2026-01-12
09421028113571Enztec Classic OCI - Trinket 3/8-24 UNF-01ENZTEC LIMITEDHWA2026-01-12
04026575448500General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
04026575448517General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
04026575448524General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
09421038410516 ATTUNE FEMORAL IMPACTORENZTEC LIMITEDHWA2025-10-21
09421038410523ATTUNE FEMORAL IMPACTOR HEADENZTEC LIMITEDHWA2025-10-21
00190446924470DJO SURGICALEncore Medical, L.P.HWA2025-10-10
09309000394289MAC SurgicalMAC SURGICAL PTY LTDHWA2025-09-30
09309000394296MAC SurgicalMAC SURGICAL PTY LTDHWA2025-09-30