SCS Claris Spinal System, Lengthened Lateral Connector, Model AL06
FDA 510(k) K021379 · Ortho Tec, LLC
510(k) numberK021379
Submission
- Device name
- SCS Claris Spinal System, Lengthened Lateral Connector, Model AL06
- Applicant
- Ortho Tec, LLC
Chesterland, OH, US - Received
- May 1, 2002
- Decision date
- May 31, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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| K031452 | Oria Spinal Clip System, Sacral Connector, Models CA03 and AO03KWP · Special | 06/18/2003SE |
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| K023377 | Oria Cervical PlatesKWQ · Traditional | 03/04/2003SE |
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Questions and answers
When was SCS Claris Spinal System, Lengthened Lateral Connector, Model AL06 cleared by the FDA?
SCS Claris Spinal System, Lengthened Lateral Connector, Model AL06 (K021379) received a 510(k) decision of Substantially Equivalent on May 31, 2002, 30 days after the submission was received.
What is the product code of K021379?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.