Pagoda Pedicle Screw System
FDA 510(k) K131785 · Ortho Development Corp.
510(k) numberK131785
Submission
- Device name
- Pagoda Pedicle Screw System
- Applicant
- Ortho Development Corp.
Draper, UT, US - Received
- June 18, 2013
- Decision date
- August 20, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
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| K253045 | Socko Vimax Spinal Fixation SystemNKB · Traditional | Socko Medical Co., Ltd. | 06/17/2026SE |
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Questions and answers
When was Pagoda Pedicle Screw System cleared by the FDA?
Pagoda Pedicle Screw System (K131785) received a 510(k) decision of Substantially Equivalent on August 20, 2013, 63 days after the submission was received.
What is the product code of K131785?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.