510(k) K122292

RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM by Reliance Medical Systems, LLC — Product Code KWP

K122292 is an FDA 510(k) premarket notification submitted by Reliance Medical Systems, LLC for the device "RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 24, 2012. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Reliance Medical Systems, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 24, 2012
Date Received
Jul 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type