Atlas FDA

BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS

FDA 510(k) clearance K992899 · decided 1999-10-21

Clearance details

K-number
K992899
Device name
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
1999-08-30
Decision date
1999-10-21
Days to decision
52 days
Clearance type
Traditional
Product code
KWS
Device class
2
Regulation number
888.3660
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Arthrex Univers Apex OptiFit Humeral Stem (K230513)Arthrex, Inc.2023-09-26
AltiVate® Anatomic Shoulder AG e+™ with Markers (K222592)Encore Medical L.P.2023-06-23
AETOS Shoulder System (K230572)Smith & Nephew, Inc.2023-06-07
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Recalls involving this device

No recalls on record reference this clearance.

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