Biomet: Solitaire PEEK Anterior Spinal System
K2M: Chesapeake Spinal System
K2M: Pyrenees Cervical Plate, Semi-Constrained Screws
LDR Spine: USA Spine Tune Ti Spine System
Medicrea: Impix Manta Cervical Interbody Device
Medicrea: Pass LP Spinal System
Spineart: Romeo Posterior Osteosynthesis System
Spinecraft: Apex Spine System 5.5mm Ti Rod & Polyaxial Screw Washer
Spinefrontier: Indus Anterior Cervical Plate
Stryker: AVS Align PEEK Spacers
Stryker: Modification to Oasys Posterior Cervical System
Synthes: Matrix MIS Rods
Zimmer: Trabvecular Metal VBR Replacement System Instrument Set
This is my favorite part of this blog, MM...thank you and keep them coming!
ReplyDeleteHere is a few more...some duplicates from the original:
ReplyDeleteThe FDA issued 49 orthopedic- and spine-related 510(k) clearances in March, according to a report by the FDA.
1. Disposable circular stapler, models WHY-25, WHY-29, WHY-32, from Changzhou Waston Medical Appliances
2. Pro-Fix precision fixation system model PFM#, PFB#, PFT# from Osteogenics Biomedical
3. C-MOR Visualization Device from Axis Surgical Technologies
4. A-GRIX resorbable bone void filled from AG Digital Technology
5. Medacta bipolar head from Medacta International
6. Synthes external fixation devices from Synthes
7. DJO Surgical Revision Femoral Hip System, model 428-14/24-140/200; 428-00-050/110, from Encore Medical
8. Aesculap Hydrolift VBR System from Aesculap
9. Trabecular Metal vertebral body replacement system instrument set from Zimmer
10. Vericore abutment in titanium for implant systems from Whip-Mix
11. Smith & Nephew Footprint Ultra PK suture anchor from Smith & Nephew Endoscopy
12. Evolution MP total knee system from Wright Medical Technology
13. Pass LP Spinal System from Medicrea Technologies
14. Chesapeake Spinal System from K2M
15. Biosure Sync tibial fixation device, in 6mm, 8mm, 10mm and 12mm sizes, from Smith & Nephew Endoscopy
16. Tibial Baseplate Augment, models KC-22118, KC-22128, KC-22138, KC-22148, KC-22158, from Omni Life Science
17. Optilock variable-angle locking distal radius plating system from Biomet Trauma
18. Stryker Arthroscope from Stryker Endoscopy
19. Synthes Matrix rods from Synthes
20. Solitaire and Solitaire Peek anterior spinal system from Biomet Spine
21. TC plating system from Ortho-Pro
22. Fixit headrest clamp system from Medicon
23. Pyrenees cervical plate system, semi-constrained screws from K2M
24. AVS Alight Peek spacers model 48328XXX, 48326XXX from Stryker
25. MBCP+ from Biomatlante
26. Spinal guides PACS from Albert Davydov
27. Apaex spine system 5.50mm titanium rod & polyxial screw washer from Spinecraft
28. Neuroscout steerable guidewire from Codman & Shurtleff
29. Impix Manta cervical interbody device from Medicrea
30. Omnitech large Trimed compression screw from Trimed
31. Versalock peek anchor with Orthocord suture, models 210818 and 210819, from Depuy Mitek
32. Versaclose model VC-200-01 from Anulex Technologies
33. Arthrex tibial graftbolt from Arthrex
34. Bio-Oss collagen from Ed. Geistlich Soehne
35. Modification to Oasys System from Stryker Spine
36. Medpor Contain implant from Porex Surgical
37. Reprocessed trocars, models B5LT and CB5LT, from Ascent Healthcare Solutions
38. Opus Speedscrew system from Arthrocare
39. SMPLE plate and screws from Biomet Trauma
40. Kneealign system with reference sensor from Orthalign
41. BI-Ostetic foam and putty, Generos foam and putty from Berkeley Advanced Biomaterials
42. Incite Inovation stand-alone interbody fusion device from Incite Innovation
43. Indus anterior cervical plate system from Spinefrontier
44. G-Force TI suture anchor system from Wright Medical Technology
45. GPC bone plates and bone screw & GPC DHS/DCS plate system from GPC Medical
46. Synthes 3.5mm quadrilateral surface plates from Synthes
47. Synthes sternal fixation system from Synthes
48. Apex-LNK acetabular insert E & F and Apex-LNK from Omni Life Science.
49. LDR Spine USA Spine Tune TL spine system from LDR Spine USA