S4 Spinal System
FDA 510(k) K130291 · Aesculap Implant System, Inc.
510(k) numberK130291
Submission
- Device name
- S4 Spinal System
- Applicant
- Aesculap Implant System, Inc.
Center Valley, PA, US - Received
- February 6, 2013
- Decision date
- April 11, 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.
Other 510(k)s with product code NKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from L&K BIOMED Co., Ltd.
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| K142707 | AIS Odontoid Fracture Fixation SystemHWC · Traditional | 12/19/2014SE |
| K142150 | Ais Modulift VBR SystemMQP · Traditional | 10/29/2014SE |
| K133802 | Ais Modulift VBR SystemMQP · Traditional | 04/17/2014SE |
| K122783 | Plasmafit Acetabular Cup and Vitelene InsertOQG · Traditional | 10/30/2013SE |
| K130887 | S4C Navigation InstrumentsOLO · Traditional | 08/13/2013SE |
| K123909 | Aesculap Cespace XPODP · Traditional | 04/15/2013SE |
| K122985 | Columbus Revision Knee SystemJWH · Special | 10/26/2012SE |
| K112551 | S4 Spinal SystemNKB · Special | 11/21/2011SE |
| K101281 | Vega Knee SystemJWH · Traditional | 07/30/2010SE |
| K100147 | S4 Cervical Occipital Plate Spinal SystemNKB · Special | 07/23/2010SE |
Questions and answers
When was S4 Spinal System cleared by the FDA?
S4 Spinal System (K130291) received a 510(k) decision of Substantially Equivalent on April 11, 2013, 64 days after the submission was received.
What is the product code of K130291?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.