Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K152000
SMV Scientific Bone Plate and Screw System · Smv Scientific · decided 2015-11-25 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| 2.5mm Drill Bit Calibrated 200mm | 110040 | Osteocentric Technologies, Inc. | HTW | 00816950028373 |
| 3.5mm Countersink | 110500 | Osteocentric Technologies, Inc. | HWW | 00816950028182 |
| 3.5mm Drill Bit X 195mm OsteoGuard | 110031 | Osteocentric Technologies, Inc. | HTW | 00816950020490 |
| Sharp Hook | 110600 | Osteocentric Technologies, Inc. | FZX | 00816950028472 |
| 3.5mm Screw Fastener Tap 110mm | 110424 | Osteocentric Technologies, Inc. | HWX | 00816950028298 |
| 2.7mm Cortical Screw Tap 145mm | 110402 | Osteocentric Technologies, Inc. | HWX | 00810074306997 |
| K-Wire Sleeve | 120001 | Osteocentric Technologies, Inc. | FZX | 00816950028021 |
| 1.5Nm Torque Limiter, AO | 120009 | Osteocentric Technologies, Inc. | HXX | 00816950028106 |
| 2.8mm Drill Bit 165mm | 110037 | Osteocentric Technologies, Inc. | HTW | 00816950028366 |
| 2.5mm Hex Driver w/AO Adapter | 110103 | Osteocentric Technologies, Inc. | HXX | 00816950028229 |
| Metaphyseal Drill Guide- Short | 120011 | Osteocentric Technologies, Inc. | FZX | 00816950028151 |
| Screw Insertion Sleeve | 120003 | Osteocentric Technologies, Inc. | FZX | 00816950028045 |
| 3.5 X 130mm Drill Bit OSTEOGUARD, P28 | 318-0001 | Osteocentric Technologies, Inc. | HTW | 00810074305020 |
| 2.5mm Drill Bit 145mm | 110014 | Osteocentric Technologies, Inc. | HTW | 00816950028250 |
| Reduction Forceps Broad | 110631 | Osteocentric Technologies, Inc. | HTD | 00816950028557 |
| Large Depth Gauge 125mm | 110202 | Osteocentric Technologies, Inc. | HTJ | 00816950029530 |
| UNIVERSAL CHUCK T HANDLE | 110350 | Osteocentric Technologies, Inc. | HXX | 00816950029943 |
| 2.0mm Drill Bit Calibrated 110mm | 110045 | Osteocentric Technologies, Inc. | HTW | 00816950028380 |
| 2.5mm Drill Bit 180mm | 110015 | Osteocentric Technologies, Inc. | HTW | 00816950028410 |
| 3.5mm/2.5mm Double Drill Sleeve | 110520 | Osteocentric Technologies, Inc. | FZX | 00816950028434 |
| Depth Gauge For Small Frag 150mm | 110206 | Osteocentric Technologies, Inc. | HTJ | 00816950028168 |
| 3.5mm/2.5mm Universal Drill Sleeve | 110522 | Osteocentric Technologies, Inc. | HXX | 00816950028212 |
| 3.5mm Drill Bit 110mm | 110028 | Osteocentric Technologies, Inc. | HTW | 00816950028243 |
| 2.5mm Drill Bit 110mm | 110013 | Osteocentric Technologies, Inc. | HTW | 00816950028267 |
| AO QC T HANDLE | 110311 | Osteocentric Technologies, Inc. | HXX | 00816950029936 |