Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial Screws)
FDA 510(k) K071921 · Innovasis, Inc.
510(k) numberK071921
Submission
- Device name
- Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial Screws)
- Applicant
- Innovasis, Inc.
Salt Lake City, UT, US - Received
- July 12, 2007
- Decision date
- November 16, 2007
- 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.
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 |
|---|---|---|
| K250076 | Endeavor Stand-Alone Cervical IBF SystemOVE · Traditional | 09/25/2025SE |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…OLO · Traditional | 07/23/2025SE |
| K250603 | AxTiHA® Stand-Alone ALIF SystemOVD · Special | 03/24/2025SE |
| K250182 | Innovasis Navigation InstrumentsOLO · Traditional | 03/24/2025SE |
| K241276 | Vector Pedicle Screw SystemNKB · Traditional | 05/20/2024SE |
| K231899 | HAtetracell-C Titanium Cervical IBF SystemODP · Traditional | 10/17/2023SE |
| K223511 | Excella Navigation InstrumentsOLO · Traditional | 05/02/2023SE |
| K223510 | Matrix HA Fusion Porous Cervical IBF SystemODP · Special | 12/12/2022SE |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemODP · Traditional | 08/26/2022SE |
| K212967 | AxTiHA Stand-Alone ALIF SystemOVD · Special | 10/15/2021SE |
Questions and answers
When was Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial Screws) cleared by the FDA?
Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial Screws) (K071921) received a 510(k) decision of Substantially Equivalent on November 16, 2007, 127 days after the submission was received.
What is the product code of K071921?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.