Isola System
FDA 510(k) K952236 · Acromed Corp.
510(k) numberK952236
Submission
- Device name
- Isola System
- Applicant
- Acromed Corp.
Cleveland, OH, US - Received
- May 12, 1995
- Decision date
- January 22, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | Reliance Medical Systems, LLC | 12/02/2016SE |
| K162801 | CastleLoc Spinal Fixation SystemMNH · Special | L&K BIOMED Co., Ltd. | 11/03/2016SE |
| K162143 | FixxSure® X-LinkMNH · Traditional | Innovasis, Inc. | 09/23/2016SE |
| K161151 | Spinal fixation systemMNH · Traditional | Canwell Medical Co., Ltd. | 09/21/2016SE |
| K162189 | ANAX 5.5 Spinal SystemMNH · Special | U&I Corporation | 08/30/2016SE |
| K151362 | HC Spinal SystemMNH · Traditional | Hung Chun Bio-S Co., Ltd. | 05/05/2016SE |
| K153404 | Zavation Spinal SystemMNH · Traditional | Zavation, LLC | 04/21/2016SE |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | Captiva Spine | 03/02/2016SE |
| K143013 | Spinal Inner Fixation SystemMNH · Traditional | Changzhou Dingjian Medical Appliance Co., Ltd. | 12/11/2015SE |
| K151695 | Romeo posterior osteosynthesis systemMNH · Traditional | Spineart | 09/10/2015SE |
More from Spineart
| 510(k) | Device | Decision |
|---|---|---|
| K980485 | Isola Spinal SystemMNI · Traditional | 10/21/1998SE |
| 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 |
Questions and answers
When was Isola System cleared by the FDA?
Isola System (K952236) received a 510(k) decision of Substantially Equivalent for Some Indications on January 22, 1996, 255 days after the submission was received.
What is the product code of K952236?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.