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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2019 | Zimmer Biomet, Inc. Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices
Item Number: 414 Terminated |
KIH | K033280 |
| Sep 16, 2015 | Orthovita, Inc., dBA Stryker Orthobiologics. Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone Terminated |
KIH | None listed |
| Jun 10, 2015 | BIOMET FRANCE S.A.R.L. The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac. Terminated |
KIH | None listed |
| Mar 12, 2012 | Stryker Instruments Div. of Stryker Corporation Flat Proximal Pressurizer.
Bone cement pressurizers are intended to help seal the delivery path between the delivery nozzle and bone in order to pressurize the cement during delivery. Terminated |
KIH | None listed |
| Sep 12, 2011 | Orthovita, Inc. Orthovita(R) Cortoss(TM) Delivery Gun
Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material Terminated |
KIH | K080108 |
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