SECULOK ACP System
FDA 510(k) K182055 · U&I Corporation
510(k) numberK182055
Submission
- Device name
- SECULOK ACP System
- Applicant
- U&I Corporation
Uijeongbu-Si, KR - Received
- July 31, 2018
- Decision date
- September 10, 2018
- 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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| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
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| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K220147 | Aspiron S ACP SystemKWQ · Special | 02/16/2022SE |
| K210573 | Velofix SA Cervical CageOVE · Traditional | 11/19/2021SE |
| K183243 | Velofix TLIF CageMAX · Special | 07/10/2019SE |
| K190067 | Velofix Interbody Fusion SystemODP · Special | 02/04/2019SE |
| K190053 | SECULOK ACP SystemKWQ · Special | 02/01/2019SE |
| K181824 | CBT Screw Fixation SystemNKB · Traditional | 12/13/2018SE |
| K183383 | ANAX OCT Spinal SystemNKG · Special | 12/12/2018SE |
| K181829 | Velofix TLIF CageMAX · Special | 11/14/2018SE |
| K180759 | SECULOK Suture AnchorMBI · Traditional | 08/09/2018SE |
| K173198 | Facet Screw Fixation SystemMRW · Traditional | 01/03/2018SE |
Questions and answers
When was SECULOK ACP System cleared by the FDA?
SECULOK ACP System (K182055) received a 510(k) decision of Substantially Equivalent on September 10, 2018, 41 days after the submission was received.
What is the product code of K182055?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.