Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X
FDA 510(k) K020085 · Sintea Biotech, Inc.
510(k) numberK020085
Submission
- Device name
- Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X
- Applicant
- Sintea Biotech, Inc.
Miami Beach, FL, US - Received
- January 10, 2002
- Decision date
- December 10, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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| K070181 | Sintea Biotech Dsc/Alf Spinal System, DSC.XX.T5.XX, ALF.XX.T5.XXMQP · Traditional | 04/18/2007SE |
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| 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 |
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Questions and answers
When was Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X cleared by the FDA?
Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X (K020085) received a 510(k) decision of Substantially Equivalent on December 10, 2002, 334 days after the submission was received.
What is the product code of K020085?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.