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20,432 catalysts · 4,728 grant · 3,622 8k filing · 2,933 device 510k · 2,761 approval · 2,000 device pma · 2,000 device recall
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20,432 catalysts · 4,728 grant · 3,622 8k filing · 2,933 device 510k · 2,761 approval · 2,000 device pma · 2,000 device recall
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system — Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer. — Status: Ongoing
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068116. 7. SPACER 6069073 CATALYFT PL40 SHORT 7MM, Model Number: 6069073. 8. SPACER 6069076 CATALYFT PL40 LONG 7MM, Model Number: 6069076. 9. SPACER 6069093 CATALYFT PL40 SHORT 9MM, Model Number: 6069093. 10. SPACER 6069096 CATALYFT PL40 LONG 9MM, Model Number: 6069096. 11. SPACER 6069113 CATALYFT PL40 SHORT 11MM, Model Number: 6069113. 12. SPACER 6069116 CATALYFT PL40 LONG 11MM, Model Number: 6069116. 13. CATALYFT PL IMPLANT SET, Model Number: SPS03143. 14. CATALYFT PL 40 IMPLANT SET, Model Number: SPS03144. 15. KIT CATALYFT PL IMPLANTS, Model Number: SPS04012. 16. KIT CATALYFT PL 40 IMPLANTS, Model Number: SPS04013. 17. CATALYFT PL 40 IMP KIT, Model Number: SPSJEP40. 18. CATALYFT PL 40 HIGH IMP KIT, Model Number: SPSJEP4H. 19. CATALYFT PL 40 SHORT IMP KIT, Model Number: SPSJEP4S. 20. CATALYFT PL 40 SHORT HIGH IMP KIT, Model Number: SPSJEP4T. 21. CATALYFT PL STRAIGHT HIGH IMP KIT, Model Number: SPSJEPSH. 22. CATALYFT PL STRAIGHT IMP KIT, Model Number: SPSJEPSI. These systems utilize the following affected Instructions for Use (IFU), Document M333023W048E, and Surgical Technique Guide, Document M333023W217. — Reason: Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur. — Status: Ongoing
HL grant. $613,399. PI: RAVI K GHANTA
DC grant. $583,125. PI: Gunnar Lennart Quass
HD grant. $29,993. PI: Leila Margaret Larson
AA grant. $282,353. PI: Meenakshi S Subbaraman
GM grant. $350,000. PI: ALEXEY V TERSKIKH
AA grant. $194,062. PI: Charlotte Goldfine
AA grant. $632,070. PI: JENNIFER A LIVINGSTON
MH grant. $438,885. PI: Stacy Renee Ryan-Pettes
TW grant. $151,200. PI: Matthew Phanchana
TW grant. $131,278. PI: Barnabas Tobi Alayande
GM grant. $79,132. PI: Kip David Lacy
TW grant. $73,847. PI: Diep Bich Nguyen
CA grant. $1,146,618. PI: Ming Yang
NS grant. $279,167. PI: AMINU ABDULLAHI TAURA
AI grant. $1,488,578. PI: Matthew E Brown
ES grant. $2,518,755. PI: Max Costa
AI grant. $126,435. PI: Jessica Ridgway
AI grant. $776,341. PI: Rashid Bashir
CA grant. $605,863. PI: Chemtai Mungo
AI grant. $225,051. PI: Adithya Cattamanchi
AG grant. $49,538. PI: Lauren Blair Wilner
AI grant. $49,538. PI: Calder R Ellsworth
HL grant. $44,916. PI: Bella Rui Shuan Weaver
LM grant. $471,544. PI: Shiv Kumar Bhatt
AG grant. $325,672. PI: Jennifer Graves
OD grant. $1,137,500. PI: Casey Harrison Halpern
AR grant. $267,423. PI: Anne R Bass
AG grant. $207,032. PI: Sarah J Barber
AI grant. $197,930. PI: Jamie L Inman
HL grant. $637,732. PI: Yajing Wang
AA grant. $169,983. PI: Cristina Miliano
TW grant. $136,718. PI: Esin Nkereuwem
CA grant. $46,368. PI: Sophia Kogut
GM grant. $350,000. PI: Alex Rojas Bie Thomsen
AA grant. $659,865. PI: MICHAEL H NATHANSON
AG grant. $107,097. PI: Frank Raven
HD grant. $3,140,397. PI: Soko Setoguchi Iwata
CA grant. $2,970,010. PI: Joshua James Meeks
AA grant. $248,997. PI: Luana Martins Carvalho
HL grant. $186,153. PI: Hope Wilson
HD grant. $563,493. PI: Leila Margaret Larson
HD grant. $499,076. PI: Jeffrey Ryan Donowitz
DK grant. $942,000. PI: Melissa Marie Crane
ES grant. $44,939. PI: Ryan Nguyen
DA grant. $141,571
CA grant. $306,265. PI: Matthew Giacalone
AR grant. $314,363. PI: Mo Chen
MH grant. $705,322. PI: Philip Andrew Chan