Excella-M Spinal System
FDA 510(k) K042143 · Innovasis, Inc.
510(k) numberK042143
Submission
- Device name
- Excella-M Spinal System
- Applicant
- Innovasis, Inc.
Salt Lake City, UT, US - Received
- August 9, 2004
- Decision date
- October 7, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation SystemKWP · Traditional | L&K BIOMED Co., Ltd. | 07/29/2015SE |
| K150753 | OASYS SystemKWP · Traditional | Stryker Corporation | 06/09/2015SE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special | Precision Spine, Inc. | 06/04/2015SE |
| K142867 | Reliance Posterior Cervical-Thoracic SystemKWP · Special | Reliance Medical Systems, LLC | 04/29/2015SE |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 04/28/2015SE |
| K142253 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/23/2015SE |
| K150229 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K143249 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K142741 | OASYS SystemKWP · Traditional | Stryker Corporation | 01/15/2015SE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special | K2m | 12/22/2014SE |
More from K2m
| 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 Excella-M Spinal System cleared by the FDA?
Excella-M Spinal System (K042143) received a 510(k) decision of Substantially Equivalent on October 7, 2004, 59 days after the submission was received.
What is the product code of K042143?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.