Reform Pedicle Screw System
FDA 510(k) K242297 · Precision Spine, Inc.
510(k) numberK242297
Submission
- Device name
- Reform Pedicle Screw System
- Applicant
- Precision Spine, Inc.
Pear, MS, US - Received
- August 2, 2024
- Decision date
- December 17, 2024
- 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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| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 07/01/2026SE |
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Questions and answers
When was Reform Pedicle Screw System cleared by the FDA?
Reform Pedicle Screw System (K242297) received a 510(k) decision of Substantially Equivalent on December 17, 2024, 137 days after the submission was received.
What is the product code of K242297?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.