Screw, Fixation, Intraosseous
Regulation 872.4880
1510(k)s in 12 months (81 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in DZL
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes (Usa) | 13 | 0 |
| Hager& Meisinger GmbH | 5 | 0 |
| Osteomed | 5 | 0 |
| KLS Martin L.P. | 4 | 0 |
| Synthes USA HQ, Inc. | 0 | 4 |
| BioHorizons Implant Systems, Inc. | 3 | 0 |
| Biomet, Inc. | 3 | 0 |
| Mitek Products | 3 | 0 |
| Osstem Implant Co., Ltd. | 3 | 0 |
| Salvin Dental Specialties | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2016 | Synthes (USA) Products LLC Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E
Product Usage:
The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and cr Terminated |
DZL | K031807 |
| Apr 5, 2016 | Synthes (USA) Products LLC Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E
Product Usage:
The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and cr Terminated |
DZL | K031807 |
| Jul 17, 2013 | Synthes USA HQ, Inc. Multi Vector Distractor Pin Holding Clamp, limited bone stock
The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as con Terminated |
DZL | K010690 |
| Mar 1, 2013 | Synthes USA HQ, Inc. Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967.
For mandibular bone lengthening. Terminated |
DZL | K010690 |
| Mar 1, 2013 | Synthes USA HQ, Inc. Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966.
For mandibular bone lengthening. Terminated |
DZL | K010690 |
| Mar 1, 2013 | Synthes USA HQ, Inc. Synthes Multi-Vector Distractor Body, Part Number 487.931.
For mandibular bone lengthening. Terminated |
DZL | K010690 |
| Aug 11, 2010 | Biomet Microfixation, Inc. BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK.
BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVIL Terminated |
DZL | K953385 |
| Jul 6, 2010 | Biomet 3i, LLC BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515.
BIOMET 3i, 4555 Riverside Dr., Palm Beach Gardens, FL. Terminated |
DZL | K874400 |
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