LZN · Cement Obturator
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | LZN |
|---|---|
| Device Name | Cement Obturator |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 37)
Showing 20 most recent of 37 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220838 | Artisan Bone Plug, Universal Cement Restrictor | Howmedica Osteonics, Dba Stryker Orthopaedics | May 20, 2022 | SESE |
| K061824 | TORNIER CEMENT RESTRICTOR | Tornier | Sep 14, 2006 | SESE |
| K032685 | CEMSTOP CEMENT RESTRICTOR | Teknimed, S.A. | Nov 26, 2003 | SESE |
| K023680 | BIOBUCK CEMENT RESTRICTOR | Smith & Nephew, Inc. | Nov 19, 2002 | SESE |
| K011943 | IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR | Kensey Nash Corp. | Sep 19, 2001 | SESE |
| K010840 | SYNPLUG | Isotis NV | Apr 20, 2001 | SESE |
| K993841 | CEMSTOP CEMENT RESTRICTOR | Encore Orthopedics, Inc. | May 4, 2000 | SESE |
| K000587 | SHUTTLE STOP | Isotis NV | May 4, 2000 | SESE |
| K992462 | OSTEONICS UNIVERSAL DISTAL CEMENT PLUG | Howmedica Osteonics Corp. | Aug 13, 1999 | SESE |
| K972411 | LINK CEMENT PLUG | Turnkey Intergration USA, Inc. | Aug 29, 1997 | SESE |
| K970779 | OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS | Osteonics Corp. | May 9, 1997 | SESE |
| K955632 | ORTHOPLUG SOFT BONE DESIGN | Sunmed, Inc. | Feb 27, 1996 | SESE |
| K955631 | ORTHOPLUG HARD BONE DESIGN | Sunmed, Inc. | Feb 27, 1996 | SESE |
| K955751 | PRIME FEMORAL CEMENT PLUG | Orthopaedic Innovations, Inc. | Jan 26, 1996 | SESE |
| K951930 | CEMENTRALIZER DISTAL STEM CENTRALIZER | Depuy, Inc. | Jul 11, 1995 | SESE |
| K951934 | PFC CEMENT RESTRICTOR | Johnson & Johnson Professionals, Inc. | May 16, 1995 | SN |
| K951860 | HOWMEDICE BONE PLUG | Howmedica Corp. | May 16, 1995 | SN |
| K933077 | EXETER INTRAMEDULLARY BONE PLUG | Howmedica Corp. | May 16, 1995 | SN |
| K943727 | BIOSTOP G BONE CEMENT RESTRICTOR | Landos, Inc. | May 11, 1995 | SESE |
| K943378 | IMPLEX CEMENT RESTRICTOR SYSTEM | Implex Corp. | Sep 23, 1994 | SESE |
Top Applicants
- Howmedica Corp. — 5 clearances
- Allo Pro Corp. — 2 clearances
- American Design Group, Inc. — 2 clearances
- Isotis NV — 2 clearances
- Johnson & Johnson Professionals, Inc. — 2 clearances
