36 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in November

Spinal Tech

The Food and Drug Administration granted 36 orthopedic- and spine-related device clearances in November. 1. Frontier Sadl Interbody Fusion Device from Frontier Medical Devices.

2. Smart Tools Knee System from Zimmer.

3. Lite Decompression System from Stryker Spine.

4. Revelation Porous Coated Hip Stem, Size 8 from Encore Medical.

5. Dymaxeon Spine System from B2B Spine.

6. Treasure Bipolar Head, Femoral Head from TGM Medical.

7. CS2 Hip System from Consensus Orthopedics.

8. Zimmer Persona the Personalized Knee System from Zimmer.

9. Hammer Toe Implant from Trilliant Surgical.

10. Pioneer Posterior Occipito-Cervico-Thoracitc System from Pioneer Surgical Technology.

11. H-Max Femoral Stems, Modular Femoral Heads, Cemented Cup, Lock Bipolar Heads from Lima Corporate.

12. Persona National Tibia Baseplates form Zimmer.

13. Vertiflex Direct Compression System from Vertiflex.

14. Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap from Brainlab.

15. Zimmer Unicompartmental Knee System Vivacit-E Articular Surface from Zimmer.

16. Pro-Link Cervical Spacer System from Life Spine.

17. CD Horizon Spire Z Spinal System from Medtronic Sofamor Danek.

18. Incite Anchored Cervical Interbody Fusion Device from Incite Innovation.

19. Synthes Matrixmadible Plate and Screw System from Synthes.

20. Zou Anterior Lumbar Plate System from Corelink.

21. Loqteq Distal Lateral Femur Plate, Cortical Screw from Aap Implantante.

22. Acumed Pelvic Bone Plate System from Acumed.

23. Compress Segmental Humeral Replacement System from Biomet.

24. S-Lok PSS System from Spinal USA.

25. Arthroscopic Surgical Instruments-Interference Screw Systems from Smith & Nephew.

26. Viceroy Spinal System from Torrey Spine.

27. Equinoxe Glenoid from Exactech.

28. Corin Trinity Acetabular Shell from Corin USA.

29. G7 Acetabular System from Biomet Manufacturing.

30. Piccolo Composite Plate System from Carbofix Orthopedics.

31. Stabiliz Fixation System from Stabiliz Orthopaedics.

32. Merete Locking Bone Plate System III from Merete Medial.

33. Illico FS Facet Fixation System from Alphatec Spine.

34. Checkmate Small Bone Fusion System from ArthroSurface.

35. Construx Mini PEEK TI Spacer System from Orthofix.

36. PrimaLIF TM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System from OsteoMed.

More Articles on Orthopedic Devices:

57 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in October

37 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in September

32 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in August


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