Testa TP Pivoting Spacer System
K-Number: K243816 · 2025-06-27
ApplicantSpine Wave, Inc.
Decision Date2025-06-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Testa TP Pivoting Spacer System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2025-06-27 under approval number K243816. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Testa TP Pivoting Spacer System?
Testa TP Pivoting Spacer System is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Spine Wave, Inc.. The 510(k) number is K243816.
When was Testa TP Pivoting Spacer System approved by the FDA?
Testa TP Pivoting Spacer System received FDA 510(k) clearance on 2025-06-27, under approval number K243816.
What company makes Testa TP Pivoting Spacer System?
Testa TP Pivoting Spacer System is manufactured by Spine Wave, Inc..
What is the FDA product code for Testa TP Pivoting Spacer System?
The FDA product code for Testa TP Pivoting Spacer System is MAX.
Other Devices by Spine Wave, Inc.
Related Devices (Code: MAX)
K163180Hubble IIOrbbo Surgical, LLC
K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc.
K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL
K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP
K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.
K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.