Atlas FDA

BENVENUE VCF OSTEO COIL SYSTEM

FDA 510(k) clearance K070293 · decided 2007-07-10

Clearance details

K-number
K070293
Device name
BENVENUE VCF OSTEO COIL SYSTEM
Applicant
Benvenue Medical, Inc.
Decision
Substantially Equivalent
Date received
2007-01-31
Decision date
2007-07-10
Days to decision
160 days
Clearance type
Traditional
Product code
OCJ
Device class
1
Regulation number
888.4540
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mountain View, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.