Apclo Pedicle Screw Systems
FDA 510(k) K112759 · Atlas Spine, Inc.
510(k) numberK112759
Submission
- Device name
- Apclo Pedicle Screw Systems
- Applicant
- Atlas Spine, Inc.
Jupiter, FL, US - Received
- September 22, 2011
- Decision date
- October 18, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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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| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy ImplantPLR · Traditional | 07/15/2026SE |
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| K192570 | Atlas Spine Expandable Cervical Standalone Interbody SystemOVE · Traditional | 02/28/2020SE |
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| K172334 | Ortus Expandable Lumbar Interbody Fusion SystemMAX · Traditional | 10/25/2017SE |
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Questions and answers
When was Apclo Pedicle Screw Systems cleared by the FDA?
Apclo Pedicle Screw Systems (K112759) received a 510(k) decision of Substantially Equivalent on October 18, 2011, 26 days after the submission was received.
What is the product code of K112759?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.