MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
FDA 510(k) K162194 · Medicrea International SA
510(k) numberK162194
Submission
- Device name
- MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
- Applicant
- Medicrea International SA
Neyron, FR - Received
- August 5, 2016
- Decision date
- December 8, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
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| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
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| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
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Questions and answers
When was MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System cleared by the FDA?
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System (K162194) received a 510(k) decision of Substantially Equivalent on December 8, 2016, 125 days after the submission was received.
What is the product code of K162194?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.