Sphynx™

FDA 510(k) K160982 · Eden Spine, LLC

Substantially Equivalent

510(k) numberK160982

Submission

Device name
Sphynx™
Applicant
Eden Spine, LLC
Atlamonte Springs, FL, US
Received
April 7, 2016
Decision date
December 22, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWQ – Appliance, Fixation, Spinal Intervertebral Body
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Specialty
Orthopedic
Implant
Yes

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More from Carlsmed, Inc.

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Questions and answers

When was Sphynx™ cleared by the FDA?

Sphynx™ (K160982) received a 510(k) decision of Substantially Equivalent on December 22, 2016, 259 days after the submission was received.

What is the product code of K160982?

The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.