Zodic Polyaxial Spinal Fixation System
FDA 510(k) K081158 · Alphatec Spine, Inc.
510(k) numberK081158
Submission
- Device name
- Zodic Polyaxial Spinal Fixation System
- Applicant
- Alphatec Spine, Inc.
Carlsbad, CA, US - Received
- April 23, 2008
- Decision date
- July 3, 2008
- 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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| K160320 | PremierMNI · Traditional | Shandong Weigao Orthopaedic Device Co., Ltd. | 04/01/2016SE |
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| K143222 | FIREFLY Pedicle Screw Navigation GuideMNI · Traditional | Mighty Oak Medical, Inc. | 12/11/2015SE |
| K150684 | WASTON General Spinal SystemMNI · Traditional | Changzhou Waston Medical Appliance Co., Ltd. | 11/18/2015SE |
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Questions and answers
When was Zodic Polyaxial Spinal Fixation System cleared by the FDA?
Zodic Polyaxial Spinal Fixation System (K081158) received a 510(k) decision of Substantially Equivalent on July 3, 2008, 71 days after the submission was received.
What is the product code of K081158?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.