Isola Spinal System
FDA 510(k) K980485 · Acromed Corp.
510(k) numberK980485
Submission
- Device name
- Isola Spinal System
- Applicant
- Acromed Corp.
Cleveland, OH, US - Received
- February 9, 1998
- Decision date
- October 21, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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| K171497 | Mikron Spinal Fixation SystemMNI · Traditional | Mikron Makina Sanayi Ticaret Co. , Ltd. | 10/12/2017SE |
| K160731 | LumFix Spinal Fixation SytemMNI · Traditional | CG Bio Co., Ltd. | 10/04/2016SE |
| K151458 | Double Medical Universal Spine SystemMNI · Traditional | Double Medical Technology, Inc. | 08/22/2016SE |
| K153273 | MySpine Pedicle Screw Placement Guides - LPMNI · Traditional | Medacta International S.A. | 06/29/2016SE |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemMNI · Special | Spinevision S.A. | 04/04/2016SE |
| K160320 | PremierMNI · Traditional | Shandong Weigao Orthopaedic Device Co., Ltd. | 04/01/2016SE |
| K160003 | Sniper (R) Spine SystemMNI · Traditional | Spine Wave, Inc. | 02/26/2016SE |
| K152324 | YAHUA Spinal SystemMNI · Traditional | Beijing Weigao Yahua Artificial Joint… | 02/01/2016SE |
| K143222 | FIREFLY Pedicle Screw Navigation GuideMNI · Traditional | Mighty Oak Medical, Inc. | 12/11/2015SE |
| K150684 | WASTON General Spinal SystemMNI · Traditional | Changzhou Waston Medical Appliance Co., Ltd. | 11/18/2015SE |
More from Changzhou Waston Medical Appliance Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K981714 | Timx Low Back System Titanium MX Rod Based Low Back SystemMNH · Traditional | 06/30/1998SE |
| K981113 | Pediatric PRCMNH · Traditional | 05/29/1998SE |
| K981274 | Acromed Timx Plate Based Low Back SystemMNH · Special | 04/29/1998SE |
| K980228 | University Plate Anterior SystemKWQ · Traditional | 04/14/1998SN |
| K974757 | Kaneda Anterior Scoliosis System KassKWQ · Traditional | 03/05/1998SN |
| K972718 | M-2 Anterior Plate SystemKWQ · Traditional | 10/01/1997SN |
| K971248 | Kaneda SR Anterior Spinal SystemKWQ · Traditional | 06/11/1997SN |
| K970955 | Acromed Anterior Cervical Stabilization SystemKWQ · Traditional | 06/11/1997SN |
| K970950 | Easy RodMNH · Traditional | 06/03/1997SE |
| K965102 | Acromed Pedicle ScrewMNH · Traditional | 05/08/1997SE |
Questions and answers
When was Isola Spinal System cleared by the FDA?
Isola Spinal System (K980485) received a 510(k) decision of Substantially Equivalent on October 21, 1998, 254 days after the submission was received.
What is the product code of K980485?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.