Capsure(R) PS System
FDA 510(k) K083353 · Spine Wave, Inc.
510(k) numberK083353
Submission
- Device name
- Capsure(R) PS System
- Applicant
- Spine Wave, Inc.
Shelton, CT, US - Received
- November 13, 2008
- Decision date
- December 11, 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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| K151458 | Double Medical Universal Spine SystemMNI · Traditional | Double Medical Technology, Inc. | 08/22/2016SE |
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| K160320 | PremierMNI · Traditional | Shandong Weigao Orthopaedic Device Co., Ltd. | 04/01/2016SE |
| K160003 | Sniper (R) Spine SystemMNI · Traditional | Spine Wave, Inc. | 02/26/2016SE |
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| K150684 | WASTON General Spinal SystemMNI · Traditional | Changzhou Waston Medical Appliance Co., Ltd. | 11/18/2015SE |
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| K231275 | Exceed Biplanar Expandable Interbody SystemMAX · Traditional | 07/25/2023SE |
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Questions and answers
When was Capsure(R) PS System cleared by the FDA?
Capsure(R) PS System (K083353) received a 510(k) decision of Substantially Equivalent on December 11, 2008, 28 days after the submission was received.
What is the product code of K083353?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.