EXPEDIUM 4.5MM SPINE SYSTEM

Thoracolumbosacral Pedicle Screw System

DEPUY SPINE, INC.

The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Expedium 4.5mm Spine System.

Pre-market Notification Details

• Device ID: K073364
• 510k Number: K073364
• Device Name: EXPEDIUM 4.5MM SPINE SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Contact: Christopher Klaczyk
• Correspondent: Christopher Klaczyk; DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-11-30
• Decision Date: 2008-04-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10705034104928	K073364	000
10705034106489	K073364	000
10705034106496	K073364	000
10705034106502	K073364	000
10705034106519	K073364	000
10705034106526	K073364	000
10705034106533	K073364	000
10705034107745	K073364	000
10705034107752	K073364	000
10705034107769	K073364	000
10705034107776	K073364	000
10705034107783	K073364	000
10705034106472	K073364	000
10705034106465	K073364	000
10705034106458	K073364	000
10705034104935	K073364	000
10705034104942	K073364	000
10705034104959	K073364	000
10705034104966	K073364	000
10705034104973	K073364	000
10705034104980	K073364	000
10705034104997	K073364	000
10705034105000	K073364	000
10705034105284	K073364	000
10705034106434	K073364	000
10705034106441	K073364	000
10705034107790	K073364	000
10705034107806	K073364	000
10705034108148	K073364	000
10705034108155	K073364	000
10705034108162	K073364	000
10705034108278	K073364	000
10705034108285	K073364	000
10705034108292	K073364	000
10705034108308	K073364	000
10705034108315	K073364	000
10705034108322	K073364	000
10705034108339	K073364	000
10705034108346	K073364	000
10705034108131	K073364	000
10705034108117	K073364	000
10705034108100	K073364	000
10705034107813	K073364	000
10705034107820	K073364	000
10705034107837	K073364	000
10705034107943	K073364	000
10705034107950	K073364	000
10705034107967	K073364	000
10705034107974	K073364	000
10705034107981	K073364	000
10705034108070	K073364	000
10705034108087	K073364	000
10705034108094	K073364	000
10705034108353	K073364	000
10705034103907	K073364	000
10705034104171	K073364	000
10705034104188	K073364	000
10705034104195	K073364	000
10705034104201	K073364	000
10705034104218	K073364	000
10705034104225	K073364	000
10705034104232	K073364	000
10705034104249	K073364	000
10705034104317	K073364	000
10705034104324	K073364	000
10705034104331	K073364	000
10705034104164	K073364	000
10705034104157	K073364	000
10705034104140	K073364	000
10705034103938	K073364	000
10705034103945	K073364	000
10705034103952	K073364	000
10705034103969	K073364	000
10705034103976	K073364	000
10705034103983	K073364	000
10705034103990	K073364	000
10705034104003	K073364	000
10705034104010	K073364	000
10705034104027	K073364	000
10705034104034	K073364	000
10705034104348	K073364	000
10705034104355	K073364	000
10705034104553	K073364	000
10705034104560	K073364	000
10705034104577	K073364	000
10705034104584	K073364	000
10705034104591	K073364	000
10705034104607	K073364	000
10705034104614	K073364	000
10705034104621	K073364	000
10705034104638	K073364	000
10705034104645	K073364	000
10705034104904	K073364	000
10705034104546	K073364	000
10705034104539	K073364	000
10705034104522	K073364	000
10705034104362	K073364	000
10705034104379	K073364	000
10705034104386	K073364	000
10705034104393	K073364	000
10705034104409	K073364	000
10705034104416	K073364	000
10705034104423	K073364	000
10705034104430	K073364	000
10705034104447	K073364	000
10705034104454	K073364	000
10705034104461	K073364	000
10705034104911	K073364	000
10705034110165	K073364	000
10705034116136	K073364	000
10705034116303	K073364	000
10705034116723	K073364	000
10705034116730	K073364	000
10705034237190	K073364	000
10705034237206	K073364	000
10705034237213	K073364	000
10705034237220	K073364	000
10705034237237	K073364	000
10705034237244	K073364	000
10705034237251	K073364	000
10705034115993	K073364	000
10705034115986	K073364	000
10705034115979	K073364	000
10705034110172	K073364	000
10705034110189	K073364	000
10705034110196	K073364	000
10705034110202	K073364	000
10705034110219	K073364	000
10705034115153	K073364	000
10705034115603	K073364	000
10705034115610	K073364	000
10705034115627	K073364	000
10705034115634	K073364	000
10705034115962	K073364	000
10705034237268	K073364	000
10705034237275	K073364	000
10705034278414	K073364	000
10705034103884	K073364	000
10705034103891	K073364	000
10705034113500	K073364	000
10705034113685	K073364	000
10705034116150	K073364	000
10705034116174	K073364	000
10705034116310	K073364	000
10705034116389	K073364	000
10705034116396	K073364	000
10705034116716	K073364	000
10705034278407	K073364	000
10705034278391	K073364	000
10705034278384	K073364	000
10705034237282	K073364	000
10705034237299	K073364	000
10705034237305	K073364	000
10705034237312	K073364	000
10705034237329	K073364	000
10705034237336	K073364	000
10705034237343	K073364	000
10705034278346	K073364	000
10705034278353	K073364	000
10705034278360	K073364	000
10705034278377	K073364	000
10705034116815	K073364	000
10705034108360	K073364	000
10705034109275	K073364	000
10705034109282	K073364	000
10705034109299	K073364	000
10705034109374	K073364	000
10705034109381	K073364	000
10705034109572	K073364	000
10705034109589	K073364	000
10705034109596	K073364	000
10705034109602	K073364	000
10705034109619	K073364	000
10705034109626	K073364	000
10705034109251	K073364	000
10705034109237	K073364	000
10705034108971	K073364	000
10705034108759	K073364	000
10705034108766	K073364	000
10705034108773	K073364	000
10705034108780	K073364	000
10705034108797	K073364	000
10705034108803	K073364	000
10705034108841	K073364	000
10705034108858	K073364	000
10705034108902	K073364	000
10705034108919	K073364	000
10705034108964	K073364	000
10705034109633	K073364	000
10705034109640	K073364	000
10705034109954	K073364	000
10705034109961	K073364	000
10705034109978	K073364	000
10705034109985	K073364	000
10705034109992	K073364	000
10705034110004	K073364	000
10705034110011	K073364	000
10705034110028	K073364	000
10705034110035	K073364	000
10705034110042	K073364	000
10705034110141	K073364	000
10705034109886	K073364	000
10705034109879	K073364	000
10705034109862	K073364	000
10705034109657	K073364	000
10705034109664	K073364	000
10705034109671	K073364	000
10705034109787	K073364	000
10705034109794	K073364	000
10705034109800	K073364	000
10705034109817	K073364	000
10705034109824	K073364	000
10705034109831	K073364	000
10705034109848	K073364	000
10705034109855	K073364	000
10705034110158	K073364	000