Atlas FDA

THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP

FDA 510(k) clearance K001039 · decided 2000-06-15

Clearance details

K-number
K001039
Device name
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
Applicant
Implex Corp.
Decision
Substantially Equivalent
Date received
2000-03-31
Decision date
2000-06-15
Days to decision
76 days
Clearance type
Abbreviated
Product code
LPH
Device class
2
Regulation number
888.3358
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Allendale, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.