Modification to Caspian Spinal System
FDA 510(k) K093534 · K2m, Inc.
510(k) numberK093534
Submission
- Device name
- Modification to Caspian Spinal System
- Applicant
- K2m, Inc.
Leesburg, VA, US - Received
- November 16, 2009
- Decision date
- December 16, 2009
- 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 |
|---|---|---|
| K260546 | Q Pedicle InstrumentsOLO · Special | 03/17/2026SE |
| K253545 | Vulcan Spinal SystemNKB · Traditional | 02/10/2026SE |
| K252873 | Q Interbody InstrumentsOLO · Traditional | 02/06/2026SE |
| K211320 | CAPRI Corpectomy Cage SystemPLR · Traditional | 02/24/2022SE |
| K202528 | Cannulated Power Driver AttachmentNKB · Traditional | 10/26/2020SE |
| K201006 | K2M Navigation InstrumentsOLO · Special | 08/07/2020SE |
| K193203 | MOJAVE Expandable Interbody SystemMAX · Special | 02/18/2020SE |
| K193129 | Yukon OCT Spinal SystemNKG · Traditional | 02/07/2020SE |
| K192911 | Brainlab Compatible K2M Navigation InstrumentsOLO · Special | 11/14/2019SE |
| K190179 | SAHARA Stabilization SystemOVD · Traditional | 10/03/2019SE |
Questions and answers
When was Modification to Caspian Spinal System cleared by the FDA?
Modification to Caspian Spinal System (K093534) received a 510(k) decision of Substantially Equivalent on December 16, 2009, 30 days after the submission was received.
What is the product code of K093534?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.