Kalitec Direct InSePtion MIS Fixation System
FDA 510(k) K163471 · Kalitec Direct, LLC
510(k) numberK163471
Submission
- Device name
- Kalitec Direct InSePtion MIS Fixation System
- Applicant
- Kalitec Direct, LLC
Orlando, FL, US - Received
- December 12, 2016
- Decision date
- March 16, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEK – Spinous Process Plate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
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| K211880 | Minuteman G5 MIS Fusion PlatePEK · Traditional | Spinal Simplicity, LLC | 03/11/2022SE |
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| K140678 | Cosmolock Pedicle Screw SystemMNH · Traditional | 06/19/2014SE |
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Questions and answers
When was Kalitec Direct InSePtion MIS Fixation System cleared by the FDA?
Kalitec Direct InSePtion MIS Fixation System (K163471) received a 510(k) decision of Substantially Equivalent on March 16, 2017, 94 days after the submission was received.
What is the product code of K163471?
The FDA product code is PEK – Spinous Process Plate, a Class II (moderate risk) device regulated under 21 CFR 888.3050.