Ghost Spacer System
K-Number: K213417 · 2022-09-29
ApplicantLife Spine, Inc.
Decision Date2022-09-29
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Ghost Spacer System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2022-09-29 under approval number K213417. 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 Ghost Spacer System?
Ghost Spacer System is a medical device that received FDA 510(k) clearance on 2022-09-29. It is manufactured by Life Spine, Inc.. The 510(k) number is K213417.
When was Ghost Spacer System approved by the FDA?
Ghost Spacer System received FDA 510(k) clearance on 2022-09-29, under approval number K213417.
What company makes Ghost Spacer System?
Ghost Spacer System is manufactured by Life Spine, Inc..
What is the FDA product code for Ghost Spacer System?
The FDA product code for Ghost Spacer System is MAX.
Other Devices by Life Spine, Inc.
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K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP
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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.