510(k) clearances

VariLift-C Cervical Interbody Fusion System

Wenzel Spine, Inc. · Orthopedic

K262595Substantially EquivalentSpecialODP
Open FDA's page for this record
Third party flag
N
City
Austin
Advisory committee description
Orthopedic
Address 1
2535 Brockton Dr.
Address 2
Suite 450
Statement or summary
Summary
Product code
ODP
Zip code
78758
Applicant
Wenzel Spine, Inc.
Decision date
2026-08-26
Decision code
SESE
Country code
US
Device name
VariLift-C Cervical Interbody Fusion System
Advisory committee
OR
Contact
Erik Emstad
K number
K262595
State
TX
Date received
2026-07-27
Review advisory committee
OR
Postal code
78758
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Intervertebral Fusion Device With Bone Graft, Cervical
Medical specialty description
Orthopedic
Regulation number
888.3080
Device class
2
Registration number
3003678543, 1000493591, 3007922509, 9617544, 3010326971, 2029275, 1000432246, 3010057495, 3012447612, 2648623, 3004635447, 3004638600, 3008285983, 1528646, 2032098, 3009998573, 3013730328, 3003387384, 3014019090, 3013462427, 1221051, 3010866843, 1424434, 3004049923, 8020776, 3005819474, 3006493760, 3043543260, 3009129735, 1836116, 3006404071, 3015542154, 3009417901, 3036496433, 3015179588, 1724955, 3011795235, 3023138345, 3022159082, 3027726367 +310 more
FEI number
3003678543, 1000493591, 3007922509, 3010326971, 1000116116, 1000432246, 3010057495, 3012447612, 2648623, 3004635447, 3004638600, 3008285983, 3002459190, 3002807113, 1000518731, 1000136451, 3009998573, 3013730328, 3003387384, 3014019090, 3013462427, 1221051, 3010866843, 3003110073, 3004049923, 3005819474, 1000115656, 3003112432, 3006493760, 3043543260, 3009129735, 3000215273, 3006404071, 3015542154, 3003142829, 3009417901, 3036496433, 3015179588, 3011795235, 3023138345 +310 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.