Construx Pl/Tl PEEK Partial VBR System
FDA 510(k) K060350 · Blackstone Medical, Inc.
510(k) numberK060350
Submission
- Device name
- Construx Pl/Tl PEEK Partial VBR System
- Applicant
- Blackstone Medical, Inc.
Wayne, NJ, US - Received
- February 10, 2006
- Decision date
- February 24, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
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| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
More from Corelink, LLC
| 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 Construx Pl/Tl PEEK Partial VBR System cleared by the FDA?
Construx Pl/Tl PEEK Partial VBR System (K060350) received a 510(k) decision of Substantially Equivalent on February 24, 2006, 14 days after the submission was received.
What is the product code of K060350?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.