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Found 6 results
510(k) Data Aggregation
K Number
K002600Device Name
LITWIN CRUICATE ANCHOR
Manufacturer
INSTRUMENT MAKAR, INC.
Date Cleared
2000-11-15
(86 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENT MAKAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K980999Device Name
ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT
Manufacturer
INSTRUMENT MAKAR, INC.
Date Cleared
1998-11-06
(233 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENT MAKAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The specific intended use of the St. Leger total knee implant is for patients suffering from pain and/or deformity of the knee joint. The pathological conditions include, but are not parted to severe degenerative arthritis, traumatic arthritis, inflammatory arthritis, and rheumatoid arthritis. The symptomatic problems include pain, decreased ambulation, inability to work, perform activities of daily living. The resulting physical deformities include loss of knee extension, knee flexion, genu valgum and genu varus. The implant may be used in revision knee surgery due to loosening, infection, or prior implant failure if the proper accompanying conditions are present and the surgeon is able to make the necessary anatomical conditions for acceptable alignment and fixation.
Device Description
Not Found
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K Number
K963396Device Name
BIOSPHERE SUTURE ANCHOR
Manufacturer
INSTRUMENT MAKAR, INC.
Date Cleared
1997-05-06
(251 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENT MAKAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K964364Device Name
DISPOSABLE APRON
Manufacturer
INSTRUMENT MAKAR, INC.
Date Cleared
1997-02-25
(116 days)
Product Code
LYU
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENT MAKAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healtheare worker from the transfer of micro-organisms. blood, body fluids and particulate material between the worker and the patient. The Disposable Apron is a disposable product intended for single use only.
Device Description
The Disposable Apron is manufactured from 6 gauge Poly Vinyl and is available in a "onc size fits most" size The apron is secured by heing slipped over the head and tied in back
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K Number
K955835Device Name
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
Manufacturer
INSTRUMENT MAKAR, INC.
Date Cleared
1996-11-19
(329 days)
Product Code
FXP
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENT MAKAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fluid Barrier Boot is intended to be used in the hospital environment to provide protection from all types of fluids in the Operating Room, Central Sterile and in the Emergency Room.
Device Description
The Fluid Barrier Boot is manufactured from 6 gauge Poly Vinyl and is available in both knee-high or ankle high boots is small, medium or large sizes. The boots are secured with straps both at the ankle and over the call on the knee-high boot. The ankle-high boot secures only at the ankle.
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K Number
K960555Device Name
BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR
Manufacturer
INSTRUMENT MAKAR, INC.
Date Cleared
1996-07-09
(151 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENT MAKAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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