Product code LZN
- Device name
- Cement Obturator
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220838 | Artisan Bone Plug, Universal Cement Restrictor | Howmedica Osteonics, Dba Stryker Orthopaedics | 2022-05-20 |
| K061824 | TORNIER CEMENT RESTRICTOR | Tornier | 2006-09-14 |
| K032685 | CEMSTOP CEMENT RESTRICTOR | Teknimed, S.A. | 2003-11-26 |
| K023680 | BIOBUCK CEMENT RESTRICTOR | Smith & Nephew, Inc. | 2002-11-19 |
| K011943 | IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR | Kensey Nash Corp. | 2001-09-19 |
| K010840 | SYNPLUG | Isotis NV | 2001-04-20 |
| K993841 | CEMSTOP CEMENT RESTRICTOR | Encore Orthopedics, Inc. | 2000-05-04 |
| K000587 | SHUTTLE STOP | Isotis NV | 2000-05-04 |
| K992462 | OSTEONICS UNIVERSAL DISTAL CEMENT PLUG | Howmedica Osteonics Corp. | 1999-08-13 |
| K972411 | LINK CEMENT PLUG | Turnkey Intergration USA, Inc. | 1997-08-29 |
| K970779 | OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS | Osteonics Corp. | 1997-05-09 |
| K955632 | ORTHOPLUG SOFT BONE DESIGN | Sunmed, Inc. | 1996-02-27 |
| K955631 | ORTHOPLUG HARD BONE DESIGN | Sunmed, Inc. | 1996-02-27 |
| K955751 | PRIME FEMORAL CEMENT PLUG | Orthopaedic Innovations, Inc. | 1996-01-26 |
| K951930 | CEMENTRALIZER DISTAL STEM CENTRALIZER | Depuy, Inc. | 1995-07-11 |
| K951934 | PFC CEMENT RESTRICTOR | Johnson & Johnson Professionals, Inc. | 1995-05-16 |
| K933077 | EXETER INTRAMEDULLARY BONE PLUG | Howmedica Corp. | 1995-05-16 |
| K951860 | HOWMEDICE BONE PLUG | Howmedica Corp. | 1995-05-16 |
| K943727 | BIOSTOP G BONE CEMENT RESTRICTOR | Landos, Inc. | 1995-05-11 |
| K943378 | IMPLEX CEMENT RESTRICTOR SYSTEM | Implex Corp. | 1994-09-23 |
| K932595 | ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR | Johnson & Johnson Orthopaedics, Inc. | 1994-09-20 |
| K942060 | P.F.C. CEMENT RESTRICTOR | Johnson & Johnson Professionals, Inc. | 1994-09-20 |
| K931847 | BIO-PREP CEMENT RESTRICTOR | Biomedical Devices, Inc. | 1994-06-28 |
| K931540 | UNIVERSAL BONE CEMENT KIT | Biodynamic Technologies, Inc. | 1994-01-27 |
| K920118 | RESORABPLUG | Sofamor Danek Mfg., Inc. | 1993-02-08 |
| K923909 | CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL | Orthomet, Inc. | 1992-11-04 |
| K911717 | ADG INTRAMEDULLARY BONE PLUG - VENTED | American Design Group, Inc. | 1991-09-04 |
| K910135 | THE UNIVERSAL CEMENT PLUG(TM) | Biotron , Ltd. | 1991-03-05 |
| K902615 | ADG BONE PLUG | American Design Group, Inc. | 1990-09-11 |
| K900392 | CENTERING PLUG | Allo Pro Corp. | 1990-03-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00889024510364 | NA | Zimmer, Inc. | 2018-09-14 |
| 00889024510357 | NA | Zimmer, Inc. | 2018-09-14 |
| 00889024376755 | NA | Zimmer, Inc. | 2016-08-31 |
| 00889024376748 | NA | Zimmer, Inc. | 2016-08-31 |
| 00889024376724 | NA | Zimmer, Inc. | 2016-08-31 |
| 00889024432918 | NA | Zimmer, Inc. | 2016-07-15 |
| 00889024433021 | NA | Zimmer, Inc. | 2016-05-24 |
| 00889024433007 | NA | Zimmer, Inc. | 2016-05-24 |
| 00889024432987 | NA | Zimmer, Inc. | 2016-05-24 |
| 00889024432956 | N/A | Zimmer, Inc. | 2016-02-04 |
| 00889024432932 | N/A | Zimmer, Inc. | 2016-02-04 |
| M68475650001001 | Perfecta | Microport Orthopedics Inc. | 2015-10-21 |
| M68475650002001 | Perfecta | Microport Orthopedics Inc. | 2015-10-21 |
| 10603295174554 | BIOSTOP | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295318088 | ELITE | DEPUY INTERNATIONAL LTD | 2015-09-24 |
| 10603295318064 | ELITE | DEPUY INTERNATIONAL LTD | 2015-09-24 |
| 10603295174578 | BIOSTOP | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 07613327051285 | NA | STRYKER CORPORATION | 2015-09-24 |
| 00889024138247 | VerSys® Advocate® | Zimmer, Inc. | 2015-09-17 |
| 00889024138261 | VerSys® Advocate® | Zimmer, Inc. | 2015-09-17 |
| 00889024138292 | VerSys® Advocate® | Zimmer, Inc. | 2015-09-17 |
| 00889024138315 | VerSys® Advocate® | Zimmer, Inc. | 2015-09-17 |
| 00889024138346 | VerSys® Advocate® | Zimmer, Inc. | 2015-09-17 |
| 00889024138216 | VerSys® Advocate® | Zimmer, Inc. | 2015-09-17 |
| 00889024138193 | VerSys® Advocate® | Zimmer, Inc. | 2015-09-17 |
| 00889024138162 | VerSys® Advocate® | Zimmer, Inc. | 2015-09-17 |
| 00889024138148 | VerSys® Advocate® | Zimmer, Inc. | 2015-09-17 |
| 00889024138117 | VerSys® Advocate® | Zimmer, Inc. | 2015-09-17 |
| 00889024138094 | VerSys® Advocate® | Zimmer, Inc. | 2015-09-17 |
| 00889024138063 | VerSys® Advocate® | Zimmer, Inc. | 2015-09-17 |