Rexious Hook Fixation Systems
FDA 510(k) K113324 · Dio Medical Co., Ltd.
510(k) numberK113324
Submission
- Device name
- Rexious Hook Fixation Systems
- Applicant
- Dio Medical Co., Ltd.
Brea, CA, US - Received
- November 10, 2011
- Decision date
- March 28, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation SystemKWP · Traditional | L&K BIOMED Co., Ltd. | 07/29/2015SE |
| K150753 | OASYS SystemKWP · Traditional | Stryker Corporation | 06/09/2015SE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special | Precision Spine, Inc. | 06/04/2015SE |
| K142867 | Reliance Posterior Cervical-Thoracic SystemKWP · Special | Reliance Medical Systems, LLC | 04/29/2015SE |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 04/28/2015SE |
| K142253 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/23/2015SE |
| K150229 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K143249 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K142741 | OASYS SystemKWP · Traditional | Stryker Corporation | 01/15/2015SE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special | K2m | 12/22/2014SE |
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| K222415 | Rexious Spinal Fixation SystemNKB · Traditional | 10/25/2022SE |
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…KWQ · Traditional | 10/18/2022SE |
| K222448 | UNITY Sacroiliac Joint Fixation SystemOUR · Traditional | 10/13/2022SE |
| K222515 | FaSet Fixation SystemMRW · Traditional | 10/05/2022SE |
| K162849 | Huvex Interspinous Fixation SystemPEK · Traditional | 02/16/2017SE |
| K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageODP · Traditional | 11/21/2016SE |
| K122872 | Intervertebral Body Fusion DeviceODP · Traditional | 02/28/2013SE |
| K121862 | Rex Anterior Cervical Plate SystemKWQ · Traditional | 10/31/2012SE |
Questions and answers
When was Rexious Hook Fixation Systems cleared by the FDA?
Rexious Hook Fixation Systems (K113324) received a 510(k) decision of Substantially Equivalent on March 28, 2012, 139 days after the submission was received.
What is the product code of K113324?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.