# Sintea Biotech, Inc.

- Location (FDA's records): Miami Beach, FL
- FDA decisions: 10 (2002–2009): 10 510(k) clearances
- Product codes: JEC (2), KWP (2), MNH (2), MQP (1), KWQ (1), HRX (1), JDW (1)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 7 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes Spine: 2 (https://510kreport.com/company/synthes-spine)
- Howmedica Osteonics Corp.: 2 (https://510kreport.com/company/howmedica-osteonics)
- Osteotech, Inc.: 1 (https://510kreport.com/company/osteotech)
- Kyphon, Inc.: 1 (https://510kreport.com/company/kyphon)
- Howmedica Corp.: 1 (https://510kreport.com/company/howmedica)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Interpore Cross Intl.: 1 (https://510kreport.com/company/interpore-cross-intl)
- Lima-Lto S.P.A.: 1 (https://510kreport.com/company/lima-lto)

## Firms that cite its devices most
- Sintea Plastek, LLC: 2 (https://510kreport.com/company/sintea-plastek)
- Sintea Plustek, LLC: 2 (https://510kreport.com/company/sintea-plustek)

## Its most-cited devices
- K020085: Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X (2002), cited by 2
- K070181: Sintea Biotech DSC/Alf Spinal System,   DSC.XX.T5.XX, Alf.XX.T5.XX (2007), cited by 1
- K041989: Sintea Biotech Anterior Plate System, Model Acp.XX.T5.X (2004), cited by 1
- K072198: X-Void, Spider (2008), cited by 1
- K043355: Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model PLS.01.T5.X (2004), cited by 1
- K081631: Sintea Biotech PLS Multi-Axial Screws (2008), cited by 1

## Recent decisions
- K082679: Laki Hand Fixation System, Model TFX.3X.06.X (Apr 7, 2009)
- K081631: Sintea Biotech PLS Multi-Axial Screws (Jul 18, 2008)
- K072198: X-Void, Spider (Jun 6, 2008)
- K070181: Sintea Biotech DSC/Alf Spinal System,   DSC.XX.T5.XX, Alf.XX.T5.XX (Apr 18, 2007)
- K060513: Sintea Biotech PLS Multi-Axial Screws, Model PLS.XX.T5.X (Mar 10, 2006)
- K043355: Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model PLS.01.T5.X (Dec 17, 2004)
- K041989: Sintea Biotech Anterior Plate System, Model Acp.XX.T5.X (Sep 16, 2004)
- K031154: Sintea Biotech Schanz Screw, Model TFX.SS.XX.X (Jun 24, 2003)

Source page: https://510kreport.com/company/sintea-biotech