PGS 5.5 MM Cannulated Pedicle Screw
FDA 510(k) K141282 · Pinnacle Spine Group
510(k) numberK141282
Submission
- Device name
- PGS 5.5 MM Cannulated Pedicle Screw
- Applicant
- Pinnacle Spine Group
Colorado Springs, CO, US - Received
- May 16, 2014
- Decision date
- December 2, 2014
- 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 |
| K253045 | Socko Vimax Spinal Fixation SystemNKB · Traditional | Socko Medical Co., Ltd. | 06/17/2026SE |
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| K260989 | Varion Thoracolumbar Fixation SystemNKB · Traditional | Kyocera Medical Technologies Inc. (KMTI) | 05/15/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | Globus Medical, Inc. | 05/07/2026SE |
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Questions and answers
When was PGS 5.5 MM Cannulated Pedicle Screw cleared by the FDA?
PGS 5.5 MM Cannulated Pedicle Screw (K141282) received a 510(k) decision of Substantially Equivalent on December 2, 2014, 200 days after the submission was received.
What is the product code of K141282?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.