Panels › Orthopedic › Product code KIH · Class 1
Dispenser, Cement
Regulation 888.4200
0510(k)s in 12 months (11 all time)
0recalls in 12 months (5 all time)
2recalls that name a 510(k)
Top companies in KIH
| Company | 510(k)s | Recalls |
|---|---|---|
| Howmedica Corp. | 3 | 0 |
| Dentsply Intl. | 2 | 0 |
| Johnson & Johnson Professionals, Inc. | 2 | 0 |
| BIOMET FRANCE S.A.R.L. | 0 | 1 |
| Depuy, Inc. | 1 | 0 |
| DePuy Orthopaedics, Inc. | 1 | 0 |
| Orthovita, Inc. | 0 | 1 |
| Orthovita, Inc., dBA Stryker Orthobiologics. | 0 | 1 |
| Precision Medical Devices, Inc. | 1 | 0 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2004 | K042591 | SMARTMIX PRE-FILLED MIXING SYSTEM DePuy Orthopaedics, Inc. | KIH |
| Dec 21, 1994 | K943906 | P.F.C. CEMENT PRESSURIZING SYSTEM Johnson & Johnson Professionals, Inc. | KIH |
| Mar 2, 1990 | K897134 | CMW CEMENT PRESSURISATION SYSTEM Dentsply Intl. | KIH |
| Jun 13, 1985 | K851881 | ORTHOPEADIC CEMENT DELIVERY SYSTEM Dentsply Intl. | KIH |
| Feb 9, 1984 | K840046 | PRESSURIZING/SCAVENGING ACRYLIC CEMENT Precision Medical Devices, Inc. | KIH |
| Dec 12, 1983 | K833675 | BRIGHAM TIBIAL CEMENT PRESSURIZER Howmedica Corp. | KIH |
| May 29, 1981 | K811317 | HOWMEDICA FEMORAL PRESSURING SEAL Howmedica Corp. | KIH |
| Jul 28, 1980 | K801388 | OH-HARRIS Johnson & Johnson Professionals, Inc. | KIH |
| Feb 21, 1979 | K790275 | GUN, EXETER CEMENT Howmedica Corp. | KIH |
| Dec 4, 1978 | K781955 | GUN, CEMENT Depuy, Inc. | KIH |
| Feb 28, 1978 | K780266 | BONE CEMENT APPLICATOR Zimmer, Inc. | KIH |
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