Sintea Biotech PLS Multi-Axial Screws, Model PLS.XX.T5.X
FDA 510(k) K060513 · Sintea Biotech, Inc.
510(k) numberK060513
Submission
- Device name
- Sintea Biotech PLS Multi-Axial Screws, Model PLS.XX.T5.X
- Applicant
- Sintea Biotech, Inc.
Miami Beach, FL, US - Received
- February 27, 2006
- Decision date
- March 10, 2006
- 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 |
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| K082679 | Laki Hand Fixation System, Model TFX.3X.06.XJEC · Special | 04/07/2009SE |
| K081631 | Sintea Biotech PLS Multi-Axial ScrewsMNH · Special | 07/18/2008SE |
| K072198 | X-Void, SpiderHRX · Traditional | 06/06/2008SE |
| K070181 | Sintea Biotech Dsc/Alf Spinal System, DSC.XX.T5.XX, ALF.XX.T5.XXMQP · Traditional | 04/18/2007SE |
| K043355 | Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model…KWP · Special | 12/17/2004SE |
| K041989 | Sintea Biotech Anterior Plate System, Model ACP.XX.T5.XKWQ · Traditional | 09/16/2004SE |
| K031154 | Sintea Biotech Schanz Screw, Model Tfx.Ss.Xx.XJDW · Traditional | 06/24/2003SE |
| K020085 | Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XMNH · Traditional | 12/10/2002SE |
| K022065 | Sintea Biotech Traumafix System, Model TFX.00.00.XJEC · Traditional | 08/06/2002SE |
Questions and answers
When was Sintea Biotech PLS Multi-Axial Screws, Model PLS.XX.T5.X cleared by the FDA?
Sintea Biotech PLS Multi-Axial Screws, Model PLS.XX.T5.X (K060513) received a 510(k) decision of Substantially Equivalent on March 10, 2006, 11 days after the submission was received.
What is the product code of K060513?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.