Panels › General, Plastic Surgery › Product code LZN · Class 2
Cement Obturator
Regulation 878.3300
0510(k)s in 12 months (37 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in LZN
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Corporation | 0 | 7 |
| Howmedica Corp. | 5 | 0 |
| Allo Pro Corp. | 2 | 0 |
| American Design Group, Inc. | 2 | 0 |
| Isotis NV | 2 | 0 |
| Johnson & Johnson Professionals, Inc. | 2 | 0 |
| Sunmed, Inc. | 2 | 0 |
| Biodynamic Technologies, Inc. | 1 | 0 |
| Biomedical Devices, Inc. | 1 | 0 |
| Biotron , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 20, 2022 | K220838 | Artisan Bone Plug, Universal Cement Restrictor Howmedica Osteonics, Dba Stryker Orthopaedics | LZN |
| Sep 14, 2006 | K061824 | TORNIER CEMENT RESTRICTOR Tornier, FR | LZN |
| Nov 26, 2003 | K032685 | CEMSTOP CEMENT RESTRICTOR Teknimed, S.A. | LZN |
| Nov 19, 2002 | K023680 | BIOBUCK CEMENT RESTRICTOR Smith & Nephew, Inc. | LZN |
| Sep 19, 2001 | K011943 | IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR Kensey Nash Corp. | LZN |
| Apr 20, 2001 | K010840 | SYNPLUG Isotis NV | LZN |
| May 4, 2000 | K993841 | CEMSTOP CEMENT RESTRICTOR Encore Orthopedics, Inc. | LZN |
| May 4, 2000 | K000587 | SHUTTLE STOP Isotis NV | LZN |
| Aug 13, 1999 | K992462 | OSTEONICS UNIVERSAL DISTAL CEMENT PLUG Howmedica Osteonics Corp. | LZN |
| Aug 29, 1997 | K972411 | LINK CEMENT PLUG Turnkey Intergration USA, Inc. | LZN |
| May 9, 1997 | K970779 | OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS Osteonics Corp. | LZN |
| Feb 27, 1996 | K955632 | ORTHOPLUG SOFT BONE DESIGN Sunmed, Inc. | LZN |
| Feb 27, 1996 | K955631 | ORTHOPLUG HARD BONE DESIGN Sunmed, Inc. | LZN |
| Jan 26, 1996 | K955751 | PRIME FEMORAL CEMENT PLUG Orthopaedic Innovations, Inc. | LZN |
| Jul 11, 1995 | K951930 | CEMENTRALIZER DISTAL STEM CENTRALIZER Depuy, Inc. | LZN |
| May 16, 1995 | K951934 | PFC CEMENT RESTRICTOR Johnson & Johnson Professionals, Inc. | LZN |
| May 16, 1995 | K951860 | HOWMEDICE BONE PLUG Howmedica Corp. | LZN |
| May 16, 1995 | K933077 | EXETER INTRAMEDULLARY BONE PLUG Howmedica Corp. | LZN |
| May 11, 1995 | K943727 | BIOSTOP G BONE CEMENT RESTRICTOR Landos, Inc. | LZN |
| Sep 23, 1994 | K943378 | IMPLEX CEMENT RESTRICTOR SYSTEM Implex Corp. | LZN |
| Sep 20, 1994 | K942060 | P.F.C. CEMENT RESTRICTOR Johnson & Johnson Professionals, Inc. | LZN |
| Sep 20, 1994 | K932595 | ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR Johnson & Johnson Orthopaedics, Inc. | LZN |
| Jun 28, 1994 | K931847 | BIO-PREP CEMENT RESTRICTOR Biomedical Devices, Inc. | LZN |
| Jan 27, 1994 | K931540 | UNIVERSAL BONE CEMENT KIT Biodynamic Technologies, Inc. | LZN |
| Feb 8, 1993 | K920118 | RESORABPLUG Sofamor Danek Mfg., Inc. | LZN |
| Nov 4, 1992 | K923909 | CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL Orthomet, Inc. | LZN |
| Sep 4, 1991 | K911717 | ADG INTRAMEDULLARY BONE PLUG - VENTED American Design Group, Inc. | LZN |
| Mar 5, 1991 | K910135 | THE UNIVERSAL CEMENT PLUG(TM) Biotron , Ltd. | LZN |
| Sep 11, 1990 | K902615 | ADG BONE PLUG American Design Group, Inc. | LZN |
| Mar 1, 1990 | K900392 | CENTERING PLUG Allo Pro Corp. | LZN |
| Feb 3, 1989 | K890326 | HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG Howmedica Corp. | LZN |
| Sep 24, 1985 | K853186 | SILASTIC INFLATABLE BONE PLUG H.P. Dow Corning Corp. Healthcare Industries Materials | LZN |
| Aug 12, 1985 | K852449 | HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER Howmedica Corp. | LZN |
| Apr 12, 1983 | K830949 | POLYETHYLENE MEDULLARY PLUG - STIIHMER/ Allo Pro Corp. | LZN |
| Feb 23, 1981 | K810353 | HARRIS CEMENT RESTRICTOR Cintor Orthopaedic Div. | LZN |
| Jun 27, 1979 | K791125 | PLUG-LOK CEMENT RESTIRCTOR Richard'S Medical Equip., Inc. | LZN |
| Aug 4, 1977 | K771408 | WROUGHT (FORGED) VITALLIUM Howmedica Corp. | LZN |
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