Px HA PEEK IBF System

Intervertebral Fusion Device With Bone Graft, Lumbar

INNOVASIS, INC.

The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Px Ha Peek Ibf System.

Pre-market Notification Details

• Device ID: K151785
• 510k Number: K151785
• Device Name: Px HA PEEK IBF System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107
• Contact: Marshall Mccarty
• Correspondent: Marshall Mccarty; INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-01
• Decision Date: 2015-10-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M711HA10112200	K151785	000
M711HA10082550	K151785	000
M711HA10082500	K151785	000
M711HA10082250	K151785	000
M711HA10082200	K151785	000
M711HA08162550	K151785	000
M711HA08162500	K151785	000
M711HA08162250	K151785	000
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M711HA08152200	K151785	000
M711HA10082800	K151785	000
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M711HA10103200	K151785	000
M711HA10102800	K151785	000
M711HA10102550	K151785	000
M711HA10102500	K151785	000
M711HA10102250	K151785	000
M711HA10102200	K151785	000
M711HA10093200	K151785	000
M711HA10092800	K151785	000
M711HA10092550	K151785	000
M711HA10092500	K151785	000
M711HA10092250	K151785	000
M711HA10092200	K151785	000
M711HA08142550	K151785	000
M711HA08142500	K151785	000
M711HA08102550	K151785	000
M711HA08102500	K151785	000
M711HA08102250	K151785	000
M711HA08102200	K151785	000
M711HA08092550	K151785	000
M711HA08092500	K151785	000
M711HA08092250	K151785	000
M711HA08092200	K151785	000
M711HA08082550	K151785	000
M711HA08082500	K151785	000
M711HA08082250	K151785	000
M711HA08082200	K151785	000
M711HA08112200	K151785	000
M711HA08112250	K151785	000
M711HA08142250	K151785	000
M711HA08142200	K151785	000
M711HA08132550	K151785	000
M711HA08132500	K151785	000
M711HA08132250	K151785	000
M711HA08132200	K151785	000
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M711HA12163200	K151785	000
M711HA10112250	K151785	000
M711HA12163000	K151785	000
M711HA12113000	K151785	000
M711HA12112800	K151785	000
M711HA12103200	K151785	000
M711HA12103000	K151785	000
M711HA12102800	K151785	000
M711HA12093200	K151785	000
M711HA12093000	K151785	000
M711HA12092800	K151785	000
M711HA12082800	K151785	000
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M711HA10162250	K151785	000
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M711HA12122800	K151785	000
M711HA12162800	K151785	000
M711HA12153200	K151785	000
M711HA12153000	K151785	000
M711HA12152800	K151785	000
M711HA12143200	K151785	000
M711HA12143000	K151785	000
M711HA12142800	K151785	000
M711HA12133200	K151785	000
M711HA12133000	K151785	000
M711HA12132800	K151785	000
M711HA12123200	K151785	000
M711HA12123000	K151785	000
M711HA10162200	K151785	000
M711HA10153200	K151785	000
M711HA10132500	K151785	000
M711HA10132250	K151785	000
M711HA10132200	K151785	000
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M711HA10122800	K151785	000
M711HA10122550	K151785	000
M711HA10122500	K151785	000
M711HA10122250	K151785	000
M711HA10122200	K151785	000
M711HA10113200	K151785	000
M711HA10112800	K151785	000
M711HA10112550	K151785	000
M711HA10132550	K151785	000
M711HA10132800	K151785	000
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M711HA10152250	K151785	000
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M711HA10143200	K151785	000
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M711HA10142550	K151785	000
M711HA10142500	K151785	000
M711HA10142250	K151785	000
M711HA10142200	K151785	000
M711HA10133200	K151785	000
M711HA10112500	K151785	000