Atlas FDA

MODIFICATION TO LUCENT

FDA 510(k) clearance K081968 · decided 2008-08-05

Clearance details

K-number
K081968
Device name
MODIFICATION TO LUCENT
Applicant
Spinal Elements, Inc.
Decision
Substantially Equivalent
Date received
2008-07-10
Decision date
2008-08-05
Days to decision
26 days
Clearance type
Special
Product code
MAX
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Carlsbad, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.