Atlas FDA

INTEGRATED ENDOSCOPY SYSTEM 1000

FDA 510(k) clearance K920800 · decided 1992-06-30

Clearance details

K-number
K920800
Device name
INTEGRATED ENDOSCOPY SYSTEM 1000
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
1992-02-21
Decision date
1992-06-30
Days to decision
130 days
Clearance type
Traditional
Product code
HRX
Device class
2
Regulation number
888.1100
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Various trauma and sports medicine instruments and implants. Arthroscope. recall (Z-1818-2016)Biomet, Inc.2016-05-26

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