Spinal Concepts, Inc. Bacfix Ti Spinal System
FDA 510(k) K030087 · Spinal Concepts, Inc.
510(k) numberK030087
Submission
- Device name
- Spinal Concepts, Inc. Bacfix Ti Spinal System
- Applicant
- Spinal Concepts, Inc.
Austin, TX, US - Received
- January 9, 2003
- Decision date
- July 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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.
| 510(k) | Device | Decision |
|---|---|---|
| K051000 | Fortitude Vue Vertebral Body Replacement DeviceMQP · Special | 05/19/2005SE |
| K050706 | Harmony Port System, Model 1907 SeriesGZT · Traditional | 04/15/2005SE |
| K040096 | Spinal Concepts, Inc. Tandem Spinous Process Plate SystemKWP · Traditional | 07/01/2004SE |
| K033663 | Spinal Concepts Inc. CodaMQP · Traditional | 05/27/2004SE |
| K033517 | Spinal Concepts Inc. Cadence and TraxisMQP · Special | 02/18/2004SE |
| K031855 | Spinal Concepts, Inc. Insight Pedicle Screw SystemKWQ · Traditional | 09/17/2003SE |
| K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation SystemMNI · Traditional | 09/11/2003SE |
| K031318 | Traxis Cement RestrictorJDK · Special | 08/22/2003SESU |
| K031672 | Spinal Concepts, Inc. Infix SystemMQP · Traditional | 08/07/2003SE |
| K031837 | Modification to Fortitude Cement RestrictorJDK · Special | 07/24/2003SE |
Questions and answers
When was Spinal Concepts, Inc. Bacfix Ti Spinal System cleared by the FDA?
Spinal Concepts, Inc. Bacfix Ti Spinal System (K030087) received a 510(k) decision of Substantially Equivalent on July 17, 2003, 189 days after the submission was received.
What is the product code of K030087?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.