Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
FDA 510(k) K183588 · Choicespine
510(k) numberK183588
Submission
- Device name
- Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
- Applicant
- Choicespine
Knoxville, TN, US - Received
- December 21, 2018
- Decision date
- February 22, 2019
- 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
Other 510(k)s with product code MQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| 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 |
|---|---|---|
| K190227 | Boomerang Anterior Cervical Plate SystemKWQ · Traditional | 05/01/2019SE |
| K183397 | ChoiceSpine Stealth Cervical Spacer SystemODP · Special | 03/06/2019SE |
| K182721 | Choice Spine Navigation SystemOLO · Traditional | 01/08/2019SE |
| K183214 | Raven Lumbar Plate SystemKWQ · Traditional | 01/03/2019SE |
| K180519 | HARRIER-SA Lumbar Interbody SystemOVD · Traditional | 05/16/2018SE |
| K172816 | TiGer Shark SystemMAX · Traditional | 01/26/2018SE |
| K173215 | Choice Spine Laminoplasty Fixation SystemNQW · Traditional | 01/19/2018SE |
| K171489 | Acapella Cervical Spacer SystemOVE · Traditional | 10/23/2017SE |
| K171686 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemMQP · Traditional | 09/15/2017SE |
| K171456 | Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw SystemsNKB · Traditional | 08/03/2017SE |
Questions and answers
When was Choice Spine Hawkeye Vertebral Body Replacement (VBR) System cleared by the FDA?
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System (K183588) received a 510(k) decision of Substantially Equivalent on February 22, 2019, 63 days after the submission was received.
What is the product code of K183588?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.