LIFE SPINE STAND-ALONE SPACER SYSTEM

Intervertebral Fusion Device With Integrated Fixation, Lumbar

LIFE SPINE

The following data is part of a premarket notification filed by Life Spine with the FDA for Life Spine Stand-alone Spacer System.

Pre-market Notification Details

• Device ID: K091301
• 510k Number: K091301
• Device Name: LIFE SPINE STAND-ALONE SPACER SYSTEM
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169
• Contact: Michael S Butler
• Correspondent: Michael S Butler; LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-05-04
• Decision Date: 2009-12-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00190837042004	K091301	000
00190837042141	K091301	000
00190837042158	K091301	000
00190837042165	K091301	000
00190837042172	K091301	000
00190837042189	K091301	000
00190837042196	K091301	000
00190837042202	K091301	000
00190837042219	K091301	000
00190837042226	K091301	000
00190837042233	K091301	000
00190837042134	K091301	000
00190837042127	K091301	000
00190837042110	K091301	000
00190837042011	K091301	000
00190837042028	K091301	000
00190837042035	K091301	000
00190837042042	K091301	000
00190837042059	K091301	000
00190837042066	K091301	000
00190837042073	K091301	000
00190837042080	K091301	000
00190837042097	K091301	000
00190837042103	K091301	000
00190837042240	K091301	000
00190837042257	K091301	000
00190837042394	K091301	000
00190837042400	K091301	000
00190837042417	K091301	000
00190837042424	K091301	000
00190837042431	K091301	000
00190837042448	K091301	000
00190837042455	K091301	000
00190837042462	K091301	000
00190837042479	K091301	000
00190837042486	K091301	000
00190837042387	K091301	000
00190837042370	K091301	000
00190837042363	K091301	000
00190837042264	K091301	000
00190837042271	K091301	000
00190837042288	K091301	000
00190837042295	K091301	000
00190837042301	K091301	000
00190837042318	K091301	000
00190837042325	K091301	000
00190837042332	K091301	000
00190837042349	K091301	000
00190837042356	K091301	000
00190837042493	K091301	000
00190837030285	K091301	000
00190837041649	K091301	000
00190837041656	K091301	000
00190837041663	K091301	000
00190837041670	K091301	000
00190837041687	K091301	000
00190837041694	K091301	000
00190837041700	K091301	000
00190837041717	K091301	000
00190837041724	K091301	000
00190837041731	K091301	000
00190837041632	K091301	000
00190837041625	K091301	000
00190837041618	K091301	000
00190837030292	K091301	000
00190837041526	K091301	000
00190837041533	K091301	000
00190837041540	K091301	000
00190837041557	K091301	000
00190837041564	K091301	000
00190837041571	K091301	000
00190837041588	K091301	000
00190837041595	K091301	000
00190837041601	K091301	000
00190837041748	K091301	000
00190837041755	K091301	000
00190837041892	K091301	000
00190837041908	K091301	000
00190837041915	K091301	000
00190837041922	K091301	000
00190837041939	K091301	000
00190837041946	K091301	000
00190837041953	K091301	000
00190837041960	K091301	000
00190837041977	K091301	000
00190837041984	K091301	000
00190837041885	K091301	000
00190837041878	K091301	000
00190837041861	K091301	000
00190837041762	K091301	000
00190837041779	K091301	000
00190837041786	K091301	000
00190837041793	K091301	000
00190837041809	K091301	000
00190837041816	K091301	000
00190837041823	K091301	000
00190837041830	K091301	000
00190837041847	K091301	000
00190837041854	K091301	000
00190837041991	K091301	000
00190837042509	K091301	000
00190837042660	K091301	000
00190837003623	K091301	000
00190837003630	K091301	000
00190837003647	K091301	000
00190837003654	K091301	000
00190837003661	K091301	000
00190837003678	K091301	000
00190837003685	K091301	000
00190837003692	K091301	000
00190837003708	K091301	000
00190837003715	K091301	000
00190837003616	K091301	000
00190837003609	K091301	000
00190837003593	K091301	000
00190837003494	K091301	000
00190837003500	K091301	000
00190837003517	K091301	000
00190837003524	K091301	000
00190837003531	K091301	000
00190837003548	K091301	000
00190837003555	K091301	000
00190837003562	K091301	000
00190837003579	K091301	000
00190837003586	K091301	000
00190837020750	K091301	000
00190837020767	K091301	000
00190837020903	K091301	000
00190837020910	K091301	000
00190837020927	K091301	000
00190837020934	K091301	000
00190837020941	K091301	000
00190837020958	K091301	000
00190837020965	K091301	000
00190837020972	K091301	000
00190837020989	K091301	000
00190837020996	K091301	000
00190837020897	K091301	000
00190837020880	K091301	000
00190837020873	K091301	000
00190837020774	K091301	000
00190837020781	K091301	000
00190837020798	K091301	000
00190837020804	K091301	000
00190837020811	K091301	000
00190837020828	K091301	000
00190837020835	K091301	000
00190837020842	K091301	000
00190837020859	K091301	000
00190837020866	K091301	000
00190837021009	K091301	000
00190837042516	K091301	000
00190837042691	K091301	000
00190837042707	K091301	000
00190837042714	K091301	000
00190837042721	K091301	000
00190837042738	K091301	000
00190837042745	K091301	000
00190837042752	K091301	000
00190837042769	K091301	000
00190837042776	K091301	000
00190837042783	K091301	000
00190837042684	K091301	000
00190837042677	K091301	000
00190837042622	K091301	000
00190837042523	K091301	000
00190837042530	K091301	000
00190837042547	K091301	000
00190837042554	K091301	000
00190837042561	K091301	000
00190837042578	K091301	000
00190837042585	K091301	000
00190837042592	K091301	000
00190837042608	K091301	000
00190837042615	K091301	000
00190837042790	K091301	000
00190837042806	K091301	000
00190837042943	K091301	000
00190837042950	K091301	000
00190837042967	K091301	000
00190837042974	K091301	000
00190837042981	K091301	000
00190837042998	K091301	000
00190837043001	K091301	000
00190837081935	K091301	000
00190837042639	K091301	000
00190837042646	K091301	000
00190837042936	K091301	000
00190837042929	K091301	000
00190837042912	K091301	000
00190837042813	K091301	000
00190837042820	K091301	000
00190837042837	K091301	000
00190837042844	K091301	000
00190837042851	K091301	000
00190837042868	K091301	000
00190837042875	K091301	000
00190837042882	K091301	000
00190837042899	K091301	000
00190837042905	K091301	000
00190837042653	K091301	000