Panels › Orthopedic › Product code LOD · Class 2
Bone Cement
Regulation 888.3027
1510(k)s in 12 months (72 all time)
6recalls in 12 months (36 all time)
16recalls that name a 510(k)
Top companies in LOD
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 10, 2004 | K033596 | CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT Exactech, Inc. | LOD |
| Apr 29, 2004 | K022688 | VERSABOND AB BONE CEMENT Smith & Nephew, Inc. | LOD |
| Feb 5, 2004 | K033563 | SMARTSET GHV GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc. | LOD |
| Feb 5, 2004 | K033382 | SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc. | LOD |
| Dec 17, 2003 | K030086 | PALACOS R BONE CEMENT WITH GENTAMICIN Biomet, Inc. | LOD |
| Nov 28, 2003 | K033509 | MODIFICATION TO VERSABOND BONE CEMENT Smith & Nephew, Inc. | LOD |
| Sep 29, 2003 | K023103 | DEPUY 1 GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc. | LOD |
| Sep 23, 2003 | K030904 | PALAMED Heraeus Medical GmbH Technology, DE | LOD |
| Sep 23, 2003 | K030903 | OSTEOPAL Heraeus Kulzer GmbH & Co. KG, DE | LOD |
| Sep 23, 2003 | K030902 | PALACOS R Heraeus Kulzer GmbH & Co. KG, DE | LOD |
| May 22, 2003 | K031430 | CEMEX SYSTEM FAST Exactech, Inc. | LOD |
| May 6, 2003 | K014199 | SURGICAL SIMPLEX P WITH TOBRAMYCIN Howmedica Osteonics Corp. | LOD |
| Feb 26, 2003 | K022251 | PALABOND Heraeus Kulzer GmbH & Co. KG, DE | LOD |
| Feb 13, 2003 | K023012 | SMARTSET HV BONE CEMENT DePuy Orthopaedics, Inc. | LOD |
| Jul 24, 2002 | K021499 | CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT DePuy Orthopaedics, Inc. | LOD |
| Jun 12, 2002 | K021715 | CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL Exactech, Inc. | LOD |
| Feb 8, 2002 | K013755 | CONCERT RADIOPAQUE BONE CEMENT Immedica, Inc. | LOD |
| Dec 19, 2001 | K993836 | GENERATION 4 BONE CEMENT Biomet, Inc. | LOD |
| Oct 30, 2001 | K010586 | PALAMED BONE CEMENT Merck Biomaterial GmbH, DE | LOD |
| Feb 8, 2001 | K000943 | CEMEX SYSTEM GUN APPLICATION VERSION Exactech, Inc. | LOD |
| Jan 26, 2001 | K002652 | SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII Stryker Corp. | LOD |
| Dec 11, 2000 | K001160 | VERSABOND BONE CEMENT Smith & Nephew, Inc. | LOD |
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