Ucr Spinal System
FDA 510(k) K032739 · Seaspine
510(k) numberK032739
Submission
- Device name
- Ucr Spinal System
- Applicant
- Seaspine
San Diego, CA, US - Received
- September 4, 2003
- Decision date
- November 20, 2003
- 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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Questions and answers
When was Ucr Spinal System cleared by the FDA?
Ucr Spinal System (K032739) received a 510(k) decision of Substantially Equivalent on November 20, 2003, 77 days after the submission was received.
What is the product code of K032739?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.