PINE Pedicle Screw System
FDA 510(k) K220285 · Tdm Co., Ltd.
510(k) numberK220285
Submission
- Device name
- PINE Pedicle Screw System
- Applicant
- Tdm Co., Ltd.
Gwangju, KR - Received
- February 1, 2022
- Decision date
- May 19, 2022
- 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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|---|---|---|---|
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 09/04/2026SE |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…NKB · Traditional | MANTIZ Co., Ltd. | 07/24/2026SE |
| K253943 | Tiger 2 SystemNKB · Traditional | Zavation Medical Products, LLC | 07/24/2026SE |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 07/14/2026SE |
| 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 |
| K251251 | ChanPin Pedicle Screw Spinal SystemNKB · Traditional | Chanpin Medtak Co., Ltd. | 06/09/2026SE |
| 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 |
| K261130 | AccelFix Spinal Fixation SystemNKB · Special | L&K BIOMED Co., Ltd. | 05/05/2026SE |
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| K232115 | TDM Large Bone Plate and Screw SystemHRS · Traditional | 04/05/2024SE |
| K231860 | TDM Screw SystemHWC · Special | 01/18/2024SE |
| K221844 | TDM Lumbar Interbody Fusion Cage SystemMAX · Traditional | 08/17/2022SE |
| K191057 | Park's Pectus SystemHRS · Traditional | 03/19/2020SE |
| K190391 | TDM Plate and Screw SystemsHRS · Traditional | 11/15/2019SE |
| K190830 | TDM Screw SystemsHWC · Traditional | 09/13/2019SE |
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Questions and answers
When was PINE Pedicle Screw System cleared by the FDA?
PINE Pedicle Screw System (K220285) received a 510(k) decision of Substantially Equivalent on May 19, 2022, 107 days after the submission was received.
What is the product code of K220285?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.