Atlas FDA

DePuy CONDUIT LLIF SQUID Inserter

FDA 510(k) clearance K220449 · decided 2022-06-28

Clearance details

K-number
K220449
Device name
DePuy CONDUIT LLIF SQUID Inserter
Applicant
Enztec Limited
Decision
Substantially Equivalent
Date received
2022-02-16
Decision date
2022-06-28
Days to decision
132 days
Clearance type
Traditional
Product code
MAX
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Middleton, NZ
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.