GAP ENDO-EXO MEDULLARY SYSTEM
K-Number: K160545 · 2016-11-23
ApplicantPega Medical, Inc.
Decision Date2016-11-23
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
GAP ENDO-EXO MEDULLARY SYSTEM is a medical device manufactured by Pega Medical, Inc.. It received FDA 510(k) clearance on 2016-11-23 under approval number K160545. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GAP ENDO-EXO MEDULLARY SYSTEM?
GAP ENDO-EXO MEDULLARY SYSTEM is a medical device that received FDA 510(k) clearance on 2016-11-23. It is manufactured by Pega Medical, Inc.. The 510(k) number is K160545.
When was GAP ENDO-EXO MEDULLARY SYSTEM approved by the FDA?
GAP ENDO-EXO MEDULLARY SYSTEM received FDA 510(k) clearance on 2016-11-23, under approval number K160545.
What company makes GAP ENDO-EXO MEDULLARY SYSTEM?
GAP ENDO-EXO MEDULLARY SYSTEM is manufactured by Pega Medical, Inc..
What is the FDA product code for GAP ENDO-EXO MEDULLARY SYSTEM?
The FDA product code for GAP ENDO-EXO MEDULLARY SYSTEM is HSB.
Related Clinical Trials
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.