PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)

Intervertebral Fusion Device With Bone Graft, Lumbar

CAPTIVA SPINE, INC

The following data is part of a premarket notification filed by Captiva Spine, Inc with the FDA for Pivotec Lumbar Interbody Fusion Device (lifd).

Pre-market Notification Details

• Device ID: K092017
• 510k Number: K092017
• Device Name: PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: CAPTIVA SPINE, INC PO BOX 1196 Pleasant Grove, UT 84062
• Contact: Mike Ensign
• Correspondent: Mike Ensign; CAPTIVA SPINE, INC PO BOX 1196 Pleasant Grove, UT 84062
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-06
• Decision Date: 2009-12-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M739PL3608	K092017	000
M739PL36150	K092017	000
M739PL3616	K092017	000
M739PL36160	K092017	000
M739PO3008	K092017	000
M739PO30080	K092017	000
M739PO3009	K092017	000
M739PO30090	K092017	000
M739PO3010	K092017	000
M739PO30100	K092017	000
M739PO3011	K092017	000
M739PO30110	K092017	000
M739PL3615	K092017	000
M739PL36140	K092017	000
M739PL3614	K092017	000
M739PL36080	K092017	000
M739PL3609	K092017	000
M739PL36090	K092017	000
M739PL3610	K092017	000
M739PL36100	K092017	000
M739PL3611	K092017	000
M739PL36110	K092017	000
M739PL3612	K092017	000
M739PL36120	K092017	000
M739PL3613	K092017	000
M739PL36130	K092017	000
M739PO3012	K092017	000
M739PO30120	K092017	000
M739PP3011	K092017	000
M739PP30110	K092017	000
M739PP3012	K092017	000
M739PP30120	K092017	000
M739PP3013	K092017	000
M739PP30130	K092017	000
M739PP3014	K092017	000
M739PP30140	K092017	000
M739PP3015	K092017	000
M739PP30150	K092017	000
M739PP3016	K092017	000
M739PP30100	K092017	000
M739PP3010	K092017	000
M739PP30090	K092017	000
M739PO3013	K092017	000
M739PO30130	K092017	000
M739PO3014	K092017	000
M739PO30140	K092017	000
M739PO3015	K092017	000
M739PO30150	K092017	000
M739PO3016	K092017	000
M739PO30160	K092017	000
M739PP3008	K092017	000
M739PP30080	K092017	000
M739PP3009	K092017	000
M739PP30160	K092017	000
M739PL3008	K092017	000
M739PL30150	K092017	000
M739PL3016	K092017	000
M739PL30160	K092017	000
M739PL3208	K092017	000
M739PL32080	K092017	000
M739PL3209	K092017	000
M739PL32090	K092017	000
M739PL3210	K092017	000
M739PL32100	K092017	000
M739PL3211	K092017	000
M739PL32110	K092017	000
M739PL3015	K092017	000
M739PL30140	K092017	000
M739PL3014	K092017	000
M739PL30080	K092017	000
M739PL3009	K092017	000
M739PL30090	K092017	000
M739PL3010	K092017	000
M739PL30100	K092017	000
M739PL3011	K092017	000
M739PL30110	K092017	000
M739PL3012	K092017	000
M739PL30120	K092017	000
M739PL3013	K092017	000
M739PL30130	K092017	000
M739PL3212	K092017	000
M739PL32120	K092017	000
M739PL3411	K092017	000
M739PL34110	K092017	000
M739PL3412	K092017	000
M739PL34120	K092017	000
M739PL3413	K092017	000
M739PL34130	K092017	000
M739PL3414	K092017	000
M739PL34140	K092017	000
M739PL3415	K092017	000
M739PL34150	K092017	000
M739PL3416	K092017	000
M739PL34100	K092017	000
M739PL3410	K092017	000
M739PL34090	K092017	000
M739PL3213	K092017	000
M739PL32130	K092017	000
M739PL3214	K092017	000
M739PL32140	K092017	000
M739PL3215	K092017	000
M739PL32150	K092017	000
M739PL3216	K092017	000
M739PL32160	K092017	000
M739PL3408	K092017	000
M739PL34080	K092017	000
M739PL3409	K092017	000
M739PL34160	K092017	000
M739PS2808	K092017	000
M739PS28150	K092017	000
M739PS2816	K092017	000
M739PS28160	K092017	000
M739PS3008	K092017	000
M739PS30080	K092017	000
M739PS3009	K092017	000
M739PS30090	K092017	000
M739PS3010	K092017	000
M739PS30100	K092017	000
M739PS3011	K092017	000
M739PS30110	K092017	000
M739PS2815	K092017	000
M739PS28140	K092017	000
M739PS2814	K092017	000
M739PS28080	K092017	000
M739PS2809	K092017	000
M739PS28090	K092017	000
M739PS2810	K092017	000
M739PS28100	K092017	000
M739PS2811	K092017	000
M739PS28110	K092017	000
M739PS2812	K092017	000
M739PS28120	K092017	000
M739PS2813	K092017	000
M739PS28130	K092017	000
M739PS3012	K092017	000
M739PS30120	K092017	000
M739PS3211	K092017	000
M739PS32110	K092017	000
M739PS3212	K092017	000
M739PS32120	K092017	000
M739PS3213	K092017	000
M739PS32130	K092017	000
M739PS3214	K092017	000
M739PS32140	K092017	000
M739PS3215	K092017	000
M739PS32150	K092017	000
M739PS3216	K092017	000
M739PS32100	K092017	000
M739PS3210	K092017	000
M739PS32090	K092017	000
M739PS3013	K092017	000
M739PS30130	K092017	000
M739PS3014	K092017	000
M739PS30140	K092017	000
M739PS3015	K092017	000
M739PS30150	K092017	000
M739PS3016	K092017	000
M739PS30160	K092017	000
M739PS3208	K092017	000
M739PS32080	K092017	000
M739PS3209	K092017	000
M739PS32160	K092017	000
M739PP3208	K092017	000
M739PP32150	K092017	000
M739PP3216	K092017	000
M739PP32160	K092017	000
M739PP3408	K092017	000
M739PP34080	K092017	000
M739PP3409	K092017	000
M739PP34090	K092017	000
M739PP3410	K092017	000
M739PP34100	K092017	000
M739PP3411	K092017	000
M739PP34110	K092017	000
M739PP3215	K092017	000
M739PP32140	K092017	000
M739PP3214	K092017	000
M739PP32080	K092017	000
M739PP3209	K092017	000
M739PP32090	K092017	000
M739PP3210	K092017	000
M739PP32100	K092017	000
M739PP3211	K092017	000
M739PP32110	K092017	000
M739PP3212	K092017	000
M739PP32120	K092017	000
M739PP3213	K092017	000
M739PP32130	K092017	000
M739PP3412	K092017	000
M739PP34120	K092017	000
M739PP3611	K092017	000
M739PP36110	K092017	000
M739PP3612	K092017	000
M739PP36120	K092017	000
M739PP3613	K092017	000
M739PP36130	K092017	000
M739PP3614	K092017	000
M739PP36140	K092017	000
M739PP3615	K092017	000
M739PP36150	K092017	000
M739PP3616	K092017	000
M739PP36100	K092017	000
M739PP3610	K092017	000
M739PP36090	K092017	000
M739PP3413	K092017	000
M739PP34130	K092017	000
M739PP3414	K092017	000
M739PP34140	K092017	000
M739PP3415	K092017	000
M739PP34150	K092017	000
M739PP3416	K092017	000
M739PP34160	K092017	000
M739PP34180	K092017	000
M739PP3608	K092017	000
M739PP3609	K092017	000
M739PP36160	K092017	000