510(k) K070369 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 9, 2007 |
| Received | Feb 8, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070369
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 66 mm Size 26, with Lock Ring, sterile, REF PT-106066, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to replace Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 70 mm Size 27, with Lock Ring, sterile, REF PT-106070, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to replace Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 74 mm Size 28, with Lock Ring, sterile, REF PT-106074, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to replace Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 48 mm Size 22, with Locking Ring, sterile, REF PT-116048, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to r Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 50 mm Size 22, with Locking Ring, sterile, REF PT-116050, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to re Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 52 mm Size 23, with Locking Ring, sterile, REF PT-116052, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to re Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 54 mm Size 23, with Locking Ring, sterile, REF PT-116054, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to r Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 56 mm Size 24, with Locking Ring, sterile, REF PT-116056, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to r Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 60 mm Size 25, with Locking Ring, sterile, REF PT-116060, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to r Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 50 mm Size 22, w/Lock Ring w/Plug, sterile, REF PT-104050, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) R Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 52 mm Size 23, w/Lock Ring w/Plug, sterile, REF PT-104052, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intende Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 56 mm Size 24, w/Lock Ring w/Plug, sterile, REF PT-104056, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intende Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 62 mm Size 25, w/Lock Ring w/Plug, sterile, REF PT-104062, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intende Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 64 mm Size 26, w/Lock Ring w/Plug, sterile, REF PT-104064, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intende Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 54 mm Size 23, with Lock Ring, sterile, REF PT-106054, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to replace Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 56 mm Size 24, with Lock Ring, sterile, REF PT-106056, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to replace Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 60 mm Size 25, with Lock Ring, sterile, REF PT-106060, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to replace Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 62 mm Size 25, with Lock Ring, sterile, REF PT-106062, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to replace Terminated |
LPH | None listed |
| Jun 8, 2011 | Biomet, Inc. Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 64 mm Size 25, with Lock Ring, sterile, REF PT-106064, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Regenerex Ringloc is intended to replace Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.