510(k) K200541
K200541 is an FDA 510(k) premarket notification submitted by Hd Lifesciences, LLC for the device "Hive Stand-alone Anterior Lumbar Interbody System". The FDA issued a decision of Substantially Equivalent on Apr 28, 2020. The device falls under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar), a Class II device regulated under 21 CFR 888.3080. Hd Lifesciences, LLC has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 28, 2020
- Date Received
- Mar 3, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.