NeoSpan Compression Staple Impant w/instruments
K-Number: K161426 · 2016-10-24
ApplicantIn2bones USA, LLC
Decision Date2016-10-24
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
NeoSpan Compression Staple Impant w/instruments is a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2016-10-24 under approval number K161426. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NeoSpan Compression Staple Impant w/instruments?
NeoSpan Compression Staple Impant w/instruments is a medical device that received FDA 510(k) clearance on 2016-10-24. It is manufactured by In2bones USA, LLC. The 510(k) number is K161426.
When was NeoSpan Compression Staple Impant w/instruments approved by the FDA?
NeoSpan Compression Staple Impant w/instruments received FDA 510(k) clearance on 2016-10-24, under approval number K161426.
What company makes NeoSpan Compression Staple Impant w/instruments?
NeoSpan Compression Staple Impant w/instruments is manufactured by In2bones USA, LLC.
What is the FDA product code for NeoSpan Compression Staple Impant w/instruments?
The FDA product code for NeoSpan Compression Staple Impant w/instruments is JDR.
Other Devices by In2bones USA, LLC
Related Devices (Code: JDR)
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.