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FDA 510(k), K113324, REXIOUS HOOK FIXATION SYSTEMS
FDA 510(k), K113324, REXIOUS HOOK FIXATION SYSTEMS
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510(K) Number: K113324
Device Name: REXIOUS HOOK FIXATION SYSTEMS
Manufacturer: APRIL LEE
Device Classification Name: Appliance, Fixation, Spinal Interlaminal
Regulation Number: KWP
Classification Product Code: KXA
Date Received: 11/10/2011
Decision Date: 03/28/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: REXIOUS HOOK FIXATION SYSTEMS
Manufacturer: APRIL LEE
Device Classification Name: Appliance, Fixation, Spinal Interlaminal
Regulation Number: KWP
Classification Product Code: KXA
Date Received: 11/10/2011
Decision Date: 03/28/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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