FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

NBD CEMENT RESTRICTOR DEVICE

K Number: K021788 · Decision Oct 4, 2002
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
53
Applicant Total
4
Review Days
126

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Basic Information

Device Name
NBD CEMENT RESTRICTOR DEVICE
K Number
K021788
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.3300
Medical Specialty
General, Plastic Surgery
Decision
Unknown
Statement or Summary
Summary
Applicant
New Business Development, LLC
Date Received
May 31, 2002
Decision Date
October 4, 2002
Product Code
JDK
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
OR
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JDK Prosthesis, Hip, Cement Restrictor

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Other Clearances by New Business Development, LLC

K Number Device Name
K072029 PHENIX VERTEBRAL BODY REPLACEMENT
K050377 NBD HEAD SCREW
K032196 NBD DISPOSABLE RF CANNULAE