Blackstone Pillar SA Partial Vertebral Body Replacement Device
FDA 510(k) K081849 · Blackstone Medical, Inc.
510(k) numberK081849
Submission
- Device name
- Blackstone Pillar SA Partial Vertebral Body Replacement Device
- Applicant
- Blackstone Medical, Inc.
Wayne, NJ, US - Received
- June 30, 2008
- Decision date
- August 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Other 510(k)s with product code OVD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
More from Alphatec Spine
| 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 |
| 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 |
| K073420 | Blackstone Ascent Multiaxial ScrewsKWP · Special | 02/14/2008SE |
Questions and answers
When was Blackstone Pillar SA Partial Vertebral Body Replacement Device cleared by the FDA?
Blackstone Pillar SA Partial Vertebral Body Replacement Device (K081849) received a 510(k) decision of Substantially Equivalent on August 28, 2008, 59 days after the submission was received.
What is the product code of K081849?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.