Infinity OCT System and PASS OCT Spinal System
FDA 510(k) K220810 · Medicrea International
510(k) numberK220810
Submission
- Device name
- Infinity OCT System and PASS OCT Spinal System
- Applicant
- Medicrea International
Rillieux-La-Pape, FR - Received
- March 21, 2022
- Decision date
- April 19, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKG – Posterior Cervical Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3075
- Specialty
- Orthopedic
- Implant
- Yes
Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following…
Other 510(k)s with product code NKG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsNKG · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/02/2026SE |
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…NKG · Traditional | CarboFix Orthopedics , Ltd. | 03/16/2026SE |
| K254165 | Infinity OCT SystemNKG · Special | Medtronic Sofamor Danek USA, Inc. | 01/21/2026SE |
| K252327 | CMORE® CT System; CMORE® CT System Navigated InstrumentsNKG · Traditional | Icotec AG | 11/12/2025SE |
| K253129 | Infinity OCT SystemNKG · Special | Medtronic Sofamor Danek USA, Inc. | 10/24/2025SE |
| K251725 | ANAX OCT Spinal SystemNKG · Special | Cg Medtech Co., Ltd. | 06/25/2025SE |
| K250866 | Sovereign Posterior Cervical SystemNKG · Traditional | Met One Technologies, LLC | 05/20/2025SE |
| K242674 | Freedom Posterior Cervical ScrewsNKG · Traditional | Signature Orthopaedics Pty, Ltd. | 05/13/2025SE |
| K250332 | Virage® OCT Spinal Fixation SystemNKG · Traditional | Highridge Medical, LLC | 04/04/2025SE |
| K242516 | EUROPA Posterior Cervical Fusion SystemNKG · Traditional | MiRus, LLC | 11/19/2024SE |
More from MiRus, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K213659 | LigaPASS 2.0 Ligament Augmentation SystemOWI · Traditional | 05/24/2022SE |
| K220724 | CD Horizon Spinal System and PASS LP Spinal SystemNKB · Special | 04/08/2022SE |
| K212005 | UNiD Spine AnalyzerLLZ · Traditional | 01/12/2022SE |
| K213281 | PASS LP Spinal System, CD Horizon Spinal SystemNKB · Traditional | 01/05/2022SE |
| K210470 | C-CURVE Interbody Fusion DeviceOVE · Traditional | 09/03/2021SE |
| K200316 | UNiD IB3D ALIFMAX · Traditional | 10/30/2020SE |
| K191134 | IB3D AlifMAX · Traditional | 10/30/2019SE |
| K182158 | UNiD Patient-matched PLIF cageMAX · Traditional | 07/15/2019SE |
| K190092 | UNiD Patient specific 3D printed TLIF cageMAX · Traditional | 05/08/2019SE |
| K190376 | PASS LP Spinal SystemNKB · Traditional | 05/02/2019SE |
Questions and answers
When was Infinity OCT System and PASS OCT Spinal System cleared by the FDA?
Infinity OCT System and PASS OCT Spinal System (K220810) received a 510(k) decision of Substantially Equivalent on April 19, 2022, 29 days after the submission was received.
What is the product code of K220810?
The FDA product code is NKG – Posterior Cervical Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3075.