CAPRI Corpectomy Cage System
FDA 510(k) K211320 · K2m, Inc.
510(k) numberK211320
Submission
- Device name
- CAPRI Corpectomy Cage System
- Applicant
- K2m, Inc.
Leesburg, VA, US - Received
- April 30, 2021
- Decision date
- February 24, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLR – Spinal Vertebral Body Replacement Device - Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Vertebral body replacement in the cervical spine.
Other 510(k)s with product code PLR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy ImplantPLR · Traditional | Atlas Spine, Inc. | 07/15/2026SE |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional | Atlas Spine, Inc. | 11/10/2025SE |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy SystemPLR · Traditional | MiRus, LLC | 10/13/2023SE |
| K221542 | Galileo Vertebral Body Replacement DevicePLR · Special | Bright Spine | 01/13/2023SE |
| K212126 | MediExpand Cervical Expandable VBR SystemPLR · Traditional | Cmf Medicon Surgical, Inc. | 04/04/2022SE |
| K192145 | Galileo Vertebral Body Replacement DevicePLR · Traditional | Bright Spine | 04/21/2020SE |
| K193412 | NEXXT MATRIXX SystemPLR · Traditional | Nexxt Spine, LLC | 02/24/2020SE |
| K190284 | Bengal Stackable Cage SystemPLR · Traditional | Medos International SARL | 12/20/2019SE |
| K190426 | ALTA Anterior Cervical Corpectomy SystemPLR · Traditional | Astura Medical, LLC | 10/24/2019SE |
| K191778 | Omnia Medical VBRPLR · Special | Omnia Medical, LLC | 08/28/2019SE |
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| K192911 | Brainlab Compatible K2M Navigation InstrumentsOLO · Special | 11/14/2019SE |
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Questions and answers
When was CAPRI Corpectomy Cage System cleared by the FDA?
CAPRI Corpectomy Cage System (K211320) received a 510(k) decision of Substantially Equivalent on February 24, 2022, 300 days after the submission was received.
What is the product code of K211320?
The FDA product code is PLR – Spinal Vertebral Body Replacement Device - Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3060.