FDA Product Code
FDA Product Code LZN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220838 | Artisan Bone Plug, Universal Cement Restrictor | Howmedica Osteonics, Dba Stryker Orthopaedics | 2022-05-20 | Traditional | PDF ↗ |
| K061824 | TORNIER CEMENT RESTRICTOR | Tornier | 2006-09-14 | Traditional | PDF ↗ |
| K032685 | CEMSTOP CEMENT RESTRICTOR | Teknimed, S.A. | 2003-11-26 | Traditional | PDF ↗ |
| K023680 | BIOBUCK CEMENT RESTRICTOR | Smith & Nephew, Inc. | 2002-11-19 | Special | PDF ↗ |
| K011943 | IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR | Kensey Nash Corp. | 2001-09-19 | Traditional | PDF ↗ |
| K010840 | SYNPLUG | Isotis NV | 2001-04-20 | Special | PDF ↗ |
| K993841 | CEMSTOP CEMENT RESTRICTOR | Encore Orthopedics, Inc. | 2000-05-04 | Traditional | PDF ↗ |
| K000587 | SHUTTLE STOP | Isotis NV | 2000-05-04 | Traditional | PDF ↗ |
| K992462 | OSTEONICS UNIVERSAL DISTAL CEMENT PLUG | Howmedica Osteonics Corp. | 1999-08-13 | Traditional | PDF ↗ |
| K972411 | LINK CEMENT PLUG | Turnkey Intergration USA, Inc. | 1997-08-29 | Traditional | PDF ↗ |
| K970779 | OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS | Osteonics Corp. | 1997-05-09 | Traditional | PDF ↗ |
| K955632 | ORTHOPLUG SOFT BONE DESIGN | Sunmed, Inc. | 1996-02-27 | Traditional | PDF ↗ |
| K955631 | ORTHOPLUG HARD BONE DESIGN | Sunmed, Inc. | 1996-02-27 | Traditional | PDF ↗ |
| K955751 | PRIME FEMORAL CEMENT PLUG | Orthopaedic Innovations, Inc. | 1996-01-26 | Traditional | PDF ↗ |
| K951930 | CEMENTRALIZER DISTAL STEM CENTRALIZER | Depuy, Inc. | 1995-07-11 | Traditional | PDF ↗ |
| K951860 | HOWMEDICE BONE PLUG | Howmedica Corp. | 1995-05-16 | Traditional | PDF ↗ |
| K933077 | EXETER INTRAMEDULLARY BONE PLUG | Howmedica Corp. | 1995-05-16 | Traditional | PDF ↗ |
| K951934 | PFC CEMENT RESTRICTOR | Johnson & Johnson Professionals, Inc. | 1995-05-16 | Traditional | PDF ↗ |
| K943727 | BIOSTOP G BONE CEMENT RESTRICTOR | Landos, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K943378 | IMPLEX CEMENT RESTRICTOR SYSTEM | Implex Corp. | 1994-09-23 | Traditional | PDF ↗ |
| K932595 | ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR | Johnson & Johnson Orthopaedics, Inc. | 1994-09-20 | Traditional | PDF ↗ |
| K942060 | P.F.C. CEMENT RESTRICTOR | Johnson & Johnson Professionals, Inc. | 1994-09-20 | Traditional | PDF ↗ |
| K931847 | BIO-PREP CEMENT RESTRICTOR | Biomedical Devices, Inc. | 1994-06-28 | Traditional | PDF ↗ |
| K931540 | UNIVERSAL BONE CEMENT KIT | Biodynamic Technologies, Inc. | 1994-01-27 | Traditional | PDF ↗ |
| K920118 | RESORABPLUG | Sofamor Danek Mfg., Inc. | 1993-02-08 | Traditional | PDF ↗ |
| K923909 | CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL | Orthomet, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K911717 | ADG INTRAMEDULLARY BONE PLUG - VENTED | American Design Group, Inc. | 1991-09-04 | Traditional | PDF ↗ |
| K910135 | THE UNIVERSAL CEMENT PLUG(TM) | Biotron , Ltd. | 1991-03-05 | Traditional | PDF ↗ |
| K902615 | ADG BONE PLUG | American Design Group, Inc. | 1990-09-11 | Traditional | PDF ↗ |
| K900392 | CENTERING PLUG | Allo Pro Corp. | 1990-03-01 | Traditional | PDF ↗ |
| K890326 | HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG | Howmedica Corp. | 1989-02-03 | Traditional | PDF ↗ |
| K853186 | SILASTIC INFLATABLE BONE PLUG H.P. | Dow Corning Corp. Healthcare Industries Materials | 1985-09-24 | Traditional | PDF ↗ |
| K852449 | HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER | Howmedica Corp. | 1985-08-12 | Traditional | PDF ↗ |
| K830949 | POLYETHYLENE MEDULLARY PLUG - STIIHMER/ | Allo Pro Corp. | 1983-04-12 | Traditional | PDF ↗ |
| K810353 | HARRIS CEMENT RESTRICTOR | Cintor Orthopaedic Div. | 1981-02-23 | Traditional | PDF ↗ |
| K791125 | PLUG-LOK CEMENT RESTIRCTOR | Richard'S Medical Equip., Inc. | 1979-06-27 | Traditional | PDF ↗ |
| K771408 | WROUGHT (FORGED) VITALLIUM | Howmedica Corp. | 1977-08-04 | Traditional | PDF ↗ |
Product code LZN · Class II · General, Plastic Surgery. Data: openFDA.