Advantage-C PEEK Cervical Lnterbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Cervical

Lntelivation, LLC

The following data is part of a premarket notification filed by Lntelivation, Llc with the FDA for Advantage-c Peek Cervical Lnterbody Fusion Device.

Pre-market Notification Details

• Device ID: K211501
• 510k Number: K211501
• Device Name: Advantage-C PEEK Cervical Lnterbody Fusion Device
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: lntelivation, LLC 70 Gruber Lane Saint Simons Island, GA 31522
• Contact: Jack Griffis
• Correspondent: Jack Griffis; lntelivation, LLC 70 Gruber Lane Saint Simons Island, GA 31522
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-05-14
• Decision Date: 2021-08-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
G079100110006S1	K211501	000
G079100120707S1	K211501	000
G079100120708S1	K211501	000
G079100120709S1	K211501	000
G079100120710S1	K211501	000
G079100120711S1	K211501	000
G079100120712S1	K211501	000
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G079100140007S1	K211501	000
G079100140008S1	K211501	000
G079100140009S1	K211501	000
G079100140010S1	K211501	000
G079100140011S1	K211501	000
G079100140012S1	K211501	000
G079100140706S1	K211501	000
G079100120706S1	K211501	000
G079100120012S1	K211501	000
G079100120011S1	K211501	000
G079100110007S1	K211501	000
G079100110008S1	K211501	000
G079100110009S1	K211501	000
G079100110010S1	K211501	000
G079100110706S1	K211501	000
G079100110707S1	K211501	000
G079100110708S1	K211501	000
G079100110709S1	K211501	000
G079100110710S1	K211501	000
G079100120006S1	K211501	000
G079100120007S1	K211501	000
G079100120008S1	K211501	000
G079100120009S1	K211501	000
G079100120010S1	K211501	000
G079100140707S1	K211501	000
G079100140708S1	K211501	000
G079100150712S1	K211501	000
G0791001520006S1	K211501	000
G0791001520007S1	K211501	000
G0791001520008S1	K211501	000
G0791001520009S1	K211501	000
G0791001520010S1	K211501	000
G0791001520011S1	K211501	000
G0791001520012S1	K211501	000
G0791001520706S1	K211501	000
G0791001520707S1	K211501	000
G0791001520708S1	K211501	000
G0791001520709S1	K211501	000
G0791001520710S1	K211501	000
G0791001520711S1	K211501	000
G079100150711S1	K211501	000
G079100150710S1	K211501	000
G079100150709S1	K211501	000
G079100140709S1	K211501	000
G079100140710S1	K211501	000
G079100140711S1	K211501	000
G079100140712S1	K211501	000
G079100150006S1	K211501	000
G079100150007S1	K211501	000
G079100150008S1	K211501	000
G079100150009S1	K211501	000
G079100150010S1	K211501	000
G079100150011S1	K211501	000
G079100150012S1	K211501	000
G079100150706S1	K211501	000
G079100150707S1	K211501	000
G079100150708S1	K211501	000
G0791001520712S1	K211501	000