Expedium Spine System
FDA 510(k) K041119 · Depuy Spine, Inc.
510(k) numberK041119
Submission
- Device name
- Expedium Spine System
- Applicant
- Depuy Spine, Inc.
Raynham, MA, US - Received
- April 29, 2004
- Decision date
- July 19, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K222276 | CONDUIT Cages; FIBERGRAFT BG PuttyODP · Traditional | 10/15/2022SE |
| K201831 | CONFIDENCE Spinal Cement SystemNDN · Traditional | 08/31/2020SE |
| K142185 | Expedium Verse Spine SystemNKB · Traditional | 11/19/2014SE |
| K111136 | Expedium Spine System, Viper System, Viper 2 SystemNKB · Traditional | 06/14/2012SESU |
| K121020 | Viper SystemNKB · Special | 05/03/2012SE |
| K110353 | Mountaineer Oct Spinal SystemKWP · Special | 04/07/2011SE |
| K110216 | Expedium System, Viper SystemNKB · Special | 04/01/2011SE |
| K103133 | Veper System, Expedium SystemNKB · Special | 01/18/2011SE |
| K101993 | Viper System, Expedium SystemNKB · Special | 12/07/2010SE |
| K101923 | Concorde Curve SystemMAX · Special | 12/01/2010SE |
Questions and answers
When was Expedium Spine System cleared by the FDA?
Expedium Spine System (K041119) received a 510(k) decision of Substantially Equivalent on July 19, 2004, 81 days after the submission was received.
What is the product code of K041119?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.