Atlas FDA

LZN

37 FDA 510(k) clearances · Product code

72 daysmedian time to decision
392 days90th percentile
37clearances measured

FDA profile

Official device name
Cement Obturator
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2009: 3 · 2010: 7 · 2012: 13 · 2014: 30 · 2015: 41 · 2020: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Artisan Bone Plug, Universal Cement Restrictor (K220838)Howmedica Osteonics, Dba Stryker Orthopaedics2022-05-20
TORNIER CEMENT RESTRICTOR (K061824)Tornier2006-09-14
CEMSTOP CEMENT RESTRICTOR (K032685)Teknimed, S.A.2003-11-26
BIOBUCK CEMENT RESTRICTOR (K023680)Smith & Nephew, Inc.2002-11-19
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR (K011943)Kensey Nash Corp.2001-09-19
SYNPLUG (K010840)Isotis NV2001-04-20
CEMSTOP CEMENT RESTRICTOR (K993841)Encore Orthopedics, Inc.2000-05-04
SHUTTLE STOP (K000587)Isotis NV2000-05-04
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG (K992462)Howmedica Osteonics Corp.1999-08-13
LINK CEMENT PLUG (K972411)Turnkey Intergration USA, Inc.1997-08-29
OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS (K970779)Osteonics Corp.1997-05-09
ORTHOPLUG SOFT BONE DESIGN (K955632)Sunmed, Inc.1996-02-27
ORTHOPLUG HARD BONE DESIGN (K955631)Sunmed, Inc.1996-02-27
PRIME FEMORAL CEMENT PLUG (K955751)Orthopaedic Innovations, Inc.1996-01-26
CEMENTRALIZER DISTAL STEM CENTRALIZER (K951930)Depuy, Inc.1995-07-11
PFC CEMENT RESTRICTOR (K951934)Johnson & Johnson Professionals, Inc.1995-05-16
HOWMEDICE BONE PLUG (K951860)Howmedica Corp.1995-05-16
EXETER INTRAMEDULLARY BONE PLUG (K933077)Howmedica Corp.1995-05-16
BIOSTOP G BONE CEMENT RESTRICTOR (K943727)Landos, Inc.1995-05-11
IMPLEX CEMENT RESTRICTOR SYSTEM (K943378)Implex Corp.1994-09-23
P.F.C. CEMENT RESTRICTOR (K942060)Johnson & Johnson Professionals, Inc.1994-09-20
ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR (K932595)Johnson & Johnson Orthopaedics, Inc.1994-09-20
BIO-PREP CEMENT RESTRICTOR (K931847)Biomedical Devices, Inc.1994-06-28
UNIVERSAL BONE CEMENT KIT (K931540)Biodynamic Technologies, Inc.1994-01-27
RESORABPLUG (K920118)Sofamor Danek Mfg., Inc.1993-02-08
CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL (K923909)Orthomet, Inc.1992-11-04
ADG INTRAMEDULLARY BONE PLUG - VENTED (K911717)American Design Group, Inc.1991-09-04
THE UNIVERSAL CEMENT PLUG(TM) (K910135)Biotron , Ltd.1991-03-05
ADG BONE PLUG (K902615)American Design Group, Inc.1990-09-11
CENTERING PLUG (K900392)Allo Pro Corp.1990-03-01
HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG (K890326)Howmedica Corp.1989-02-03
SILASTIC INFLATABLE BONE PLUG H.P. (K853186)Dow Corning Corp. Healthcare Industries Materials1985-09-24
HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER (K852449)Howmedica Corp.1985-08-12
POLYETHYLENE MEDULLARY PLUG - STIIHMER/ (K830949)Allo Pro Corp.1983-04-12
HARRIS CEMENT RESTRICTOR (K810353)Cintor Orthopaedic Div.1981-02-23
PLUG-LOK CEMENT RESTIRCTOR (K791125)Richard'S Medical Equip., Inc.1979-06-27
WROUGHT (FORGED) VITALLIUM (K771408)Howmedica Corp.1977-08-04

Track LZN automatically

Every clearance here is in the API, with alerts when new ones post.