FDA.report

LOSPA Knee System, EXULT Knee System

Primary DI
08800017205267
Brand
LOSPA Knee System, EXULT Knee System
Company
Corentec Co., Ltd
Model
KA.CPC.0002C
Device description
Patella Clamp Resection Guide Head 2
Published
2024-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LHXTrousers, Anti-Shock

Product Code Classifications

CodeDeviceSpecialtyClass
LHXTrousers, Anti-ShockCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800017205267PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic reamer guideAn orthopaedic surgical device that functions as a guide for an orthopaedic reamer. The guide, commonly called a spigot, is inserted into a predetermined site where bone is to be resected for the acceptance of a prosthetic implant, typically at or within a joint (e.g., the condyle head of the knee, the olecranon of the ulna) or for the reaming of the intramedullary canal for acceptance of an intramedullary nail. The device allows the controlled cutting action of the reamer which is steered down its length. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+820269374902ra@corentec.com

Regulatory Flags

DUNS number
688739895
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
true
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 DIBrandModelCatalogPublished
08809945895076EXULT Surgical InstrumentKZ.024.Z0232026-03-23
08806373887703BENCOX Surgical Instruments01.51.7532026-02-23
08809945895021EXULT Surgical InstrumentKZ.024.Z0182026-02-20
08809945895038EXULT Surgical InstrumentKZ.024.Z0192026-02-20
08809945895045EXULT Surgical InstrumentKZ.024.Z0202026-02-20
08809945895052EXULT Surgical InstrumentKZ.024.Z0212026-02-20
08809945895069EXULT Surgical InstrumentKZ.024.Z0222026-02-20
08809945895083EXULT Surgical InstrumentKZ.024.Z0242026-02-20
08809945895090EXULT Surgical InstrumentKZ.024.Z0252026-02-20
08809945895106EXULT Surgical InstrumentKZ.024.Z0262026-02-20
08809945895113EXULT Surgical InstrumentKZ.024.Z0272026-02-20
08809945895120EXULT Surgical InstrumentKZ.024.Z0282026-02-20
08800017271101Bencox Hip SystemHA.02J.00012018-11-21
08800017278230Bencox Hip SystemHZ.012.00012018-11-22
08800017285405Bencox Hip SystemHA.0B2.00012018-11-22
08800017299358BENCOX Surgical Instruments01.51.771.062026-01-12
08806373874215Bencox Hip SystemHA.013.00042018-11-21
08806373887734BENCOX Surgical Instruments01.51.7712026-01-12
08806373887826BENCOX Surgical Instruments01.51.8882026-01-12
08806373887833BENCOX Surgical Instruments01.51.888.012026-01-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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00198506089596ELMED INCORPORATEDELMED INCORPORATEDLHX2026-03-13
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00885556919613R3Smith & Nephew, Inc.LHX2024-11-04
00191083047300AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047317AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047324AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047331AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047348AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047355AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047362AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047379AlloWedgeRti Surgical, Inc.LHX2024-10-14
00840343722876GEN2SURGIX MEDICAL LLCLHX2024-06-28
08800068981486LOSPA Knee System, EXULT Knee SystemCorentec Co., LtdLHX2024-01-12
00840343720537GEN2SURGIX MEDICAL LLCLHX2023-12-15
00840343720957GEN2SURGIX MEDICAL LLCLHX2023-12-15
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00840343719326Gen2SURGIX MEDICAL LLCLHX2023-11-14
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10889981308322SpecialsSEASPINE ORTHOPEDICS CORPORATIONLHX2023-03-24
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10889981308346SpecialsSEASPINE ORTHOPEDICS CORPORATIONLHX2023-03-24
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10889981308438SpecialsSEASPINE ORTHOPEDICS CORPORATIONLHX2023-03-24
00850005827337GENESIS AWL/TAPPERGenesis Biologics, Inc.LHX2023-03-16
00885556850794Cadence Total Ankle SystemSmith & Nephew, Inc.LHX2023-02-02