Atlas FDA

REGENERX RINGLOC + MODULAR ACETABULAR SHELLS

FDA 510(k) clearance K070369 · decided 2007-03-09

Clearance details

K-number
K070369
Device name
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2007-02-08
Decision date
2007-03-09
Days to decision
29 days
Clearance type
Special
Product code
LPH
Device class
2
Regulation number
888.3358
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
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 50 mm Size 22, w/Lock Ring recall (Z-2448-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 52 mm Size 23, w/Lock Ring recall (Z-2449-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 56 mm Size 24, w/Lock Ring recall (Z-2450-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 62 mm Size 25, w/Lock Ring recall (Z-2451-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 64 mm Size 26, w/Lock Ring recall (Z-2452-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 54 mm Size 23, with Lock Ring, steri recall (Z-2453-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 56 mm Size 24, with Lock Ring, steri recall (Z-2454-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 60 mm Size 25, with Lock Ring, steri recall (Z-2455-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 62 mm Size 25, with Lock Ring, steri recall (Z-2456-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 64 mm Size 25, with Lock Ring, steri recall (Z-2457-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 66 mm Size 26, with Lock Ring, steri recall (Z-2458-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 70 mm Size 27, with Lock Ring, steri recall (Z-2459-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 74 mm Size 28, with Lock Ring, steri recall (Z-2460-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 48 mm Size 22, with Locking Ring, recall (Z-2461-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 50 mm Size 22, with Locking Ring, recall (Z-2462-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 52 mm Size 23, with Locking Ring, recall (Z-2463-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 54 mm Size 23, with Locking Ring, recall (Z-2464-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 56 mm Size 24, with Locking Ring, recall (Z-2465-2011)Biomet, Inc.2011-06-08
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 60 mm Size 25, with Locking Ring, recall (Z-2466-2011)Biomet, Inc.2011-06-08

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