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