Isola Polyaxial Washer
FDA 510(k) K013441 · Depuyacromed
510(k) numberK013441
Submission
- Device name
- Isola Polyaxial Washer
- Applicant
- Depuyacromed
Raynham, MA, US - Received
- October 17, 2001
- Decision date
- November 16, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
More from K2m
| 510(k) | Device | Decision |
|---|---|---|
| K040197 | Eagle Anterior Cervial Plate SystemKWQ · Special | 04/02/2004SE |
| K031635 | Depuy Acromed VBR SystemMQP · Special | 06/23/2003SE |
| K030833 | Depuy Acromed VBR SystemMQP · Special | 04/10/2003SE |
| K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsMNH · Special | 02/26/2003SE |
| K030249 | Surgical Titanium Mesh SystemMQP · Special | 02/14/2003SE |
| K030103 | Summit Oct Spinal System Minipolyaxial ScrewsMNI · Special | 02/05/2003SE |
| K023835 | Devex Mesh SystemMQP · Special | 01/29/2003SE |
| K024348 | Monarch Spine SystemMNH · Special | 01/28/2003SE |
| K023804 | Moss Miami Spinal System Pin NutKWP · Special | 01/23/2003SE |
| K021039 | Bowti Anterior Buttress Staple SystemKWQ · Traditional | 12/11/2002SE |
Questions and answers
When was Isola Polyaxial Washer cleared by the FDA?
Isola Polyaxial Washer (K013441) received a 510(k) decision of Substantially Equivalent on November 16, 2001, 30 days after the submission was received.
What is the product code of K013441?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.