Atlas FDA

icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)

FDA 510(k) clearance K232792 · decided 2024-04-05

Clearance details

K-number
K232792
Device name
icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)
Applicant
Icotec AG
Decision
Substantially Equivalent
Date received
2023-09-11
Decision date
2024-04-05
Days to decision
207 days
Clearance type
Traditional
Product code
MAX
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
9450 Altstaetten (Sg), CH
Third-party review
No
Expedited review
No

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VersaLift Expandable System (K260837)Life Spine, Inc.2026-05-12
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Recalls involving this device

No recalls on record reference this clearance.