Eminent Foot Plate System

Plate, Fixation, Bone

Eminent Spine

The following data is part of a premarket notification filed by Eminent Spine with the FDA for Eminent Foot Plate System.

Pre-market Notification Details

• Device ID: K143365
• 510k Number: K143365
• Device Name: Eminent Foot Plate System
• Classification: Plate, Fixation, Bone
• Applicant: Eminent Spine 7200 N. IH 35 Bldg. #1 Georgetown, TX 78626
• Contact: Dave Freehill
• Correspondent: Meredith May; Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-11-24
• Decision Date: 2015-03-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B014FOR45	K143365	000
B014FOL21	K143365	000
B014FMTSR3	K143365	000
B014FMTSR2	K143365	000
B014FMTSR1	K143365	000
B014FMTSL3	K143365	000
B014FMTSL2	K143365	000
B014FMTSL1	K143365	000
B014FMTR56	K143365	000
B014FMTR52	K143365	000
B014FMTR48	K143365	000
B014FMTR42	K143365	000
B014FMTR36	K143365	000
B014FMTR30	K143365	000
B014FMTR24	K143365	000
B014FMTR18	K143365	000
B014FOL27	K143365	000
B014FOL33	K143365	000
B014FOL39	K143365	000
B014FOR39	K143365	000
B014FOR33	K143365	000
B014FOR27	K143365	000
B014FOR21	K143365	000
B014FOLR45	K143365	000
B014FOLR39	K143365	000
B014FOLR33	K143365	000
B014FOLR27	K143365	000
B014FOLR21	K143365	000
B014FOLL45	K143365	000
B014FOLL39	K143365	000
B014FOLL33	K143365	000
B014FOLL27	K143365	000
B014FOLL21	K143365	000
B014FOL45	K143365	000
B014FMTL56	K143365	000
B014FMTL52	K143365	000
B014FHH18	K143365	000
B014FH24	K143365	000
B014FH22	K143365	000
B014FH20	K143365	000
B014FH18	K143365	000
B014FEP6	K143365	000
B014FEP3	K143365	000
B014FEP1	K143365	000
B014FCS2	K143365	000
B014FCS1	K143365	000
B014FCM2	K143365	000
B014FCM1	K143365	000
B014FCL2	K143365	000
B014FCL1	K143365	000
B014FC9	K143365	000
B014FHH20	K143365	000
B014FHH22	K143365	000
B014FLF18	K143365	000
B014FMTL48	K143365	000
B014FMTL42	K143365	000
B014FMTL36	K143365	000
B014FMTL30	K143365	000
B014FMTL24	K143365	000
B014FMTL18	K143365	000
B014FMT44	K143365	000
B014FMT40	K143365	000
B014FMT36	K143365	000
B014FMT30	K143365	000
B014FMT24	K143365	000
B014FMT18	K143365	000
B014FLF24	K143365	000
B014FLF22	K143365	000
B014FLF20	K143365	000
B014FC3	K143365	000
B014FOWL02	K143365	000
B014FU41	K143365	000
B014FPS3520	K143365	000
B014FPS3518	K143365	000
B014FPS3516	K143365	000
B014FPS3512	K143365	000
B014FPS2740	K143365	000
B014FPS2738	K143365	000
B014FPS2736	K143365	000
B014FPS2734	K143365	000
B014FPS2732	K143365	000
B014FPS2730	K143365	000
B014FPS2728	K143365	000
B014FPS2726	K143365	000
B014FPS2724	K143365	000
B014FPS2722	K143365	000
B014FPS2720	K143365	000
B014FPS3522	K143365	000
B014FPS3524	K143365	000
B014FPS3526	K143365	000
B014FU35	K143365	000
B014FU29	K143365	000
B014FU23	K143365	000
B014FU17	K143365	000
B014FTMT24	K143365	000
B014FTMT22	K143365	000
B014FTMT20	K143365	000
B014FTMT18	K143365	000
B014FPS3540	K143365	000
B014FPS3538	K143365	000
B014FPS3536	K143365	000
B014FPS3534	K143365	000
B014FPS3532	K143365	000
B014FPS3530	K143365	000
B014FPS3528	K143365	000
B014FPS2718	K143365	000
B014FPS2716	K143365	000
B014FPMOR21	K143365	000
B014FPMOL45	K143365	000
B014FPMOL39	K143365	000
B014FPMOL33	K143365	000
B014FPMOL27	K143365	000
B014FPMOL21	K143365	000
B014FP14	K143365	000
B014FP12	K143365	000
B014FP10	K143365	000
B014FOWR08	K143365	000
B014FOWR06	K143365	000
B014FOWR04	K143365	000
B014FOWR02	K143365	000
B014FOWL08	K143365	000
B014FOWL06	K143365	000
B014FPMOR27	K143365	000
B014FPMOR33	K143365	000
B014FPMOR39	K143365	000
B014FPS2714	K143365	000
B014FPS2712	K143365	000
B014FPS2710	K143365	000
B014FPS14	K143365	000
B014FPS12	K143365	000
B014FPS10	K143365	000
B014FPMWR04	K143365	000
B014FPMWR035	K143365	000
B014FPMWR03	K143365	000
B014FPMWR02	K143365	000
B014FPMWL04	K143365	000
B014FPMWL035	K143365	000
B014FPMWL03	K143365	000
B014FPMWL02	K143365	000
B014FPMOR45	K143365	000
B014FOWL04	K143365	000