FDA.reportPublic FDA data

510(k) K060038

Device
SBI RADIO-CAPITELLAR IMPLANT
Applicant
Small Bone Innovations, Inc.
510(k) number
K060038
Product code
JDB
Decision
Substantially Equivalent (SESE)
Decision date
2006-03-30
Date received
2006-01-06
Regulation
888.3160
Classification name
Prosthesis, Elbow, Semi-Constrained, Cemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERT HOEHN
Address
505 Park Ave. 14th Floor New York NY US 10022 10022

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K972691ABC TOTAL ELBOW PROTHESISBiomet, Inc.1997-10-15
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