Orthocaps Twinaligner
K-Number: K180241 · 2018-09-28
ApplicantOrtho Caps GmbH
Decision Date2018-09-28
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Orthocaps Twinaligner is a medical device manufactured by Ortho Caps GmbH. It received FDA 510(k) clearance on 2018-09-28 under approval number K180241. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Orthocaps Twinaligner?
Orthocaps Twinaligner is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Ortho Caps GmbH. The 510(k) number is K180241.
When was Orthocaps Twinaligner approved by the FDA?
Orthocaps Twinaligner received FDA 510(k) clearance on 2018-09-28, under approval number K180241.
What company makes Orthocaps Twinaligner?
Orthocaps Twinaligner is manufactured by Ortho Caps GmbH.
What is the FDA product code for Orthocaps Twinaligner?
The FDA product code for Orthocaps Twinaligner is NXC.
Related Devices (Code: NXC)
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.