Capsure PS System
FDA 510(k) K132154 · Spine Wave, Inc.
510(k) numberK132154
Submission
- Device name
- Capsure PS System
- Applicant
- Spine Wave, Inc.
Shelton, CT, US - Received
- July 12, 2013
- Decision date
- August 9, 2013
- 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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Questions and answers
When was Capsure PS System cleared by the FDA?
Capsure PS System (K132154) received a 510(k) decision of Substantially Equivalent on August 9, 2013, 28 days after the submission was received.
What is the product code of K132154?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.