Atlas FDA

LACTOSORB RAPIDFLAP

FDA 510(k) clearance K003281 · decided 2001-08-07

Clearance details

K-number
K003281
Device name
LACTOSORB RAPIDFLAP
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2000-10-19
Decision date
2001-08-07
Days to decision
292 days
Clearance type
Traditional
Product code
JEY
Device class
2
Regulation number
872.4760
Medical specialty
Dental
Advisory committee
Dental
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

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PMA approvals by this applicant

RecordFirmDate
C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009)Biomet, Inc.2011-02-11
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
C2-A TAPER ACETABULAR SYSTEM (P050009/S005)Biomet, Inc.2007-11-30
C2A-TAPER ACETABULAR SYSTEM (P050009/S002)Biomet, Inc.2006-06-16
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16