Blackstone Ascent Multiaxial Screws
FDA 510(k) K073420 · Blackstone Medical, Inc.
510(k) numberK073420
Submission
- Device name
- Blackstone Ascent Multiaxial Screws
- Applicant
- Blackstone Medical, Inc.
Wayne, NJ, US - Received
- December 5, 2007
- Decision date
- February 14, 2008
- 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 |
|---|---|---|
| K093926 | Firebird Spinal Fixation SystemNKB · Traditional | 07/28/2010SE |
| K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesKWQ · Traditional | 05/04/2010SE |
| K092624 | Firebird Spinal Fixation SystemNKB · Special | 09/25/2009SE |
| K082797 | Blackstone Pedicle Screw SystemNKB · Special | 10/17/2008SE |
| K081684 | Blackstone Pedicle Screw SystemNKB · Traditional | 09/15/2008SE |
| K082235 | Blackstone Pillar XL PEEK SpacersMAX · Special | 09/04/2008SE |
| K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement DeviceOVD · Special | 08/28/2008SE |
| K081177 | Blackstone Medical, Inc., Pillar Spacer SystemMAX · Traditional | 07/23/2008SE |
| K080407 | Blackstone SFS Parallel Rod ConnectorsMNI · Special | 03/13/2008SE |
| K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemKWP · Special | 03/13/2008SE |
Questions and answers
When was Blackstone Ascent Multiaxial Screws cleared by the FDA?
Blackstone Ascent Multiaxial Screws (K073420) received a 510(k) decision of Substantially Equivalent on February 14, 2008, 71 days after the submission was received.
What is the product code of K073420?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.