BOX PEEK VBR 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 Box Peek Vbr System,.

Pre-market Notification Details

• Device ID: K121581
• 510k Number: K121581
• Device Name: BOX PEEK VBR SYSTEM,
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107
• Contact: Marshall C Mccarty
• Correspondent: Marshall C 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: 2012-05-30
• Decision Date: 2012-10-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M711XLB4514000	K121581	000
M711AB1840120	K121581	000
M711AB1840060	K121581	000
M711AB1834120	K121581	000
M711AB1834060	K121581	000
M711AB1828120	K121581	000
M711AB1828060	K121581	000
M711AB1640120	K121581	000
M711AB1640060	K121581	000
M711AB1634120	K121581	000
M711AB1634060	K121581	000
M711AB1628120	K121581	000
M711AB1628060	K121581	000
M711AB2028060	K121581	000
M711AB2028120	K121581	000
M711XLB4512120	K121581	000
M711XLB4512070	K121581	000
M711XLB4512000	K121581	000
M711XLB4510120	K121581	000
M711XLB4510070	K121581	000
M711XLB4510000	K121581	000
M711XLB4508070	K121581	000
M711XLB4508000	K121581	000
M711AB2040120	K121581	000
M711AB2040060	K121581	000
M711AB2034120	K121581	000
M711AB2034060	K121581	000
M711AB1440120	K121581	000
M711AB1440060	K121581	000
M711AB1434120	K121581	000
M711AB1028060	K121581	000
M711AB0840060	K121581	000
M711AB0834060	K121581	000
M711AB0828120	K121581	000
M711AB0828060	K121581	000
M711LB1580	K121581	000
M711LB0120	K121581	000
M711LAI0300	K121581	000
M711LAI0200	K121581	000
M711LAI0100	K121581	000
M711LAA0900	K121581	000
M711LA1050	K121581	000
M711AB1028120	K121581	000
M711AB1034060	K121581	000
M711AB1434060	K121581	000
M711AB1428120	K121581	000
M711AB1428060	K121581	000
M711AB1240120	K121581	000
M711AB1240060	K121581	000
M711AB1234120	K121581	000
M711AB1234060	K121581	000
M711AB1228120	K121581	000
M711AB1228060	K121581	000
M711AB1040120	K121581	000
M711AB1040060	K121581	000
M711AB1034120	K121581	000
M711LA1040	K121581	000
M711XLB4514070	K121581	000
M711LB0100	K121581	000
M711XLC5012120	K121581	000
M711XLC5012070	K121581	000
M711XLC5012000	K121581	000
M711XLC5010120	K121581	000
M711XLC5010070	K121581	000
M711XLC5010000	K121581	000
M711XLC5008070	K121581	000
M711XLC5008000	K121581	000
M711XLC4514120	K121581	000
M711XLC4514070	K121581	000
M711XLC4514000	K121581	000
M711XLC4512120	K121581	000
M711XLC5014000	K121581	000
M711XLC5014070	K121581	000
M711XLC5514120	K121581	000
M711XLC5514070	K121581	000
M711XLC5514000	K121581	000
M711XLC5512120	K121581	000
M711XLC5512070	K121581	000
M711XLC5512000	K121581	000
M711XLC5510120	K121581	000
M711XLC5510070	K121581	000
M711XLC5510000	K121581	000
M711XLC5508070	K121581	000
M711XLC5508000	K121581	000
M711XLC5014120	K121581	000
M711XLC4512070	K121581	000
M711XLC4512000	K121581	000
M711XLC4510120	K121581	000
M711XLB5508000	K121581	000
M711XLB5014120	K121581	000
M711XLB5014070	K121581	000
M711XLB5014000	K121581	000
M711XLB5012120	K121581	000
M711XLB5012070	K121581	000
M711XLB5012000	K121581	000
M711XLB5010120	K121581	000
M711XLB5010070	K121581	000
M711XLB5010000	K121581	000
M711XLB5008070	K121581	000
M711XLB5008000	K121581	000
M711XLB5508070	K121581	000
M711XLB5510000	K121581	000
M711XLC4510070	K121581	000
M711XLC4510000	K121581	000
M711XLC4508070	K121581	000
M711XLC4508000	K121581	000
M711XLB5514120	K121581	000
M711XLB5514070	K121581	000
M711XLB5514000	K121581	000
M711XLB5512120	K121581	000
M711XLB5512070	K121581	000
M711XLB5512000	K121581	000
M711XLB5510120	K121581	000
M711XLB5510070	K121581	000
M711XLB4514120	K121581	000