FDA-Device2022-11-23Class II
OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.
Novapproach Spine LLC
Hazard
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Sold states
US Nationwide distribution in the states of CA and NY.
Affected count
6 devices
Manufactured in
13900 Tech City Cir Ste 300, N/A, Alachua, FL, United States
Products
OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0246-2023Don't want to check this manually?
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