FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM

K Number: K022246 · Decision Aug 2, 2002
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
48
Review Days
21

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Basic Information

Device Name
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K Number
K022246
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
880.5860
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Depuyacromed
Date Received
July 12, 2002
Decision Date
August 2, 2002
Product Code
FMF
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
FMF Syringe, Piston

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Other Clearances by Depuyacromed

K Number Device Name
K040197 EAGLE ANTERIOR CERVIAL PLATE SYSTEM
K031635 DEPUY ACROMED VBR SYSTEM
K030833 DEPUY ACROMED VBR SYSTEM
K030383 MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030249 SURGICAL TITANIUM MESH SYSTEM
K030103 SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS
K023835 DEVEX MESH SYSTEM
K024348 MONARCH SPINE SYSTEM
K023804 MOSS MIAMI SPINAL SYSTEM PIN NUT
K021039 BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
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