Sterile Posterior Spinal Fixation System
K-Number: K221745 · 2022-08-31
Decision Date2022-08-31
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Sterile Posterior Spinal Fixation System is a medical device manufactured by Shanghai Reach Medical Instrument Co, Ltd.. It received FDA 510(k) clearance on 2022-08-31 under approval number K221745. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sterile Posterior Spinal Fixation System?
Sterile Posterior Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-08-31. It is manufactured by Shanghai Reach Medical Instrument Co, Ltd.. The 510(k) number is K221745.
When was Sterile Posterior Spinal Fixation System approved by the FDA?
Sterile Posterior Spinal Fixation System received FDA 510(k) clearance on 2022-08-31, under approval number K221745.
What company makes Sterile Posterior Spinal Fixation System?
Sterile Posterior Spinal Fixation System is manufactured by Shanghai Reach Medical Instrument Co, Ltd..
What is the FDA product code for Sterile Posterior Spinal Fixation System?
The FDA product code for Sterile Posterior Spinal Fixation System is NKB.
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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.