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  • Depuy Cmw 2 Bone Cement - Accessdata Fda

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JUN - 8 2006 SECTION 5: 510(k) SUMMARY Trade Name: DePuy CMW 2 Bone Cement DePuy CMW 3 Bone Cement Common Name: Antibiotic bone cement Classification Name: Bone cement, antibiotic (21 CFR 888.3027,.

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Classification. Class II (special controls).

FDA Medical Device Classifications Class I: A medical device with low to moderate risk that requires general controls. Class II: A medical device with a moderate to high risk that requires special controls. Class III: A medical device with high risk that requires premarket approval.

Table 1 PowderLiquidI) Polymer: Polymethyl methacrylate/co-polymer (PMMA)I) Monomer: Methyl methacrylate (MMA)II) Initiator: Benzoyl peroxide (BPO)II) Accelerator: N, N-Dimethyl para-toluidine (DMPT)/diMethyl para-toluidine (DMpt)III) Radio-opacifier: Barium sulphate (BaSO4)/Zirconia (ZrO2)III) Stabilizer: Hydroquinone1 more row • 15 Dec 2013

Bone cements can be defined as biomaterials obtained by mixing a powder phase and a liquid phase, which can be moulded and implanted as a paste and have the ability to set once implanted within the body. They are widely used in different applications of orthopaedic surgery.

Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.

Product Description. The DePuy CMW 1 Bone Cement is a high viscosity medium-setting time bone cement relative to other DePuy Synthes PMMA cements. It provides a reliable working time for modern cementing techniques with a setting time of approximately 12.5 minutes at 19°C (66°F).4.

Bone cement, or polymethylmethacrylate (PMMA), has been used in surgical fixation of artificial joints for over 50 years. The primary function of bone cement is to transfer forces from bone to prosthesis.

FDA classifies into class II devices for which general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232