Plate, Bone
Regulation 872.4760
4510(k)s in 12 months (294 all time)
0recalls in 12 months (111 all time)
27recalls that name a 510(k)
Top companies in JEY
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Craniomaxillofacial Division | 0 | 81 |
| Synthes (Usa) | 42 | 2 |
| KLS Martin L.P. | 19 | 0 |
| Bioplate, Inc. | 16 | 2 |
| Walter Lorenz Surgical, Inc. | 15 | 3 |
| Biomet Microfixation | 8 | 7 |
| Stryker | 13 | 0 |
| Inion , Ltd. | 8 | 0 |
| Bionx Implants, Inc. | 7 | 0 |
| Medicon EG | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2010 | Biomet Microfixation, Inc. BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***.
Bone screws used along with implantable bone pl Terminated |
JEY | K953385 |
| Mar 17, 2010 | Biomet Microfixation, Inc. BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MICROFIXATION, 1520 TR Terminated |
JEY | K953385 |
| Oct 26, 2009 | Synthes USA (HQ), Inc. SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/48MM, Catalog # SD448.006.
Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surge Terminated |
JEY | None listed |
| Oct 26, 2009 | Synthes USA (HQ), Inc. SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/45MM, Catalog # SD448.005.
Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surge Terminated |
JEY | None listed |
| Oct 26, 2009 | Synthes USA (HQ), Inc. SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/42MM, Catalog # SD448.004.
Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surge Terminated |
JEY | None listed |
| Oct 26, 2009 | Synthes USA (HQ), Inc. SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/39MM, Catalog # SD448.003.
Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surge Terminated |
JEY | None listed |
| Dec 30, 2008 | Stryker Leibinger USA Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template, Stryker Leibinger GmbH & Co., Freiburg, Germany; REF # 55-28911.
A mandibular plate and screw Terminated |
JEY | K014263 |
| Nov 4, 2008 | Biomet Microfixation, Inc. HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures. Terminated |
JEY | K001238 |
| Sep 16, 2008 | Biomet Microfixation, Inc. Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive surgical procedures in Terminated |
JEY | K955729 K980927 |
| Oct 19, 2006 | Bioplate Inc Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45 Terminated |
JEY | K051845 |
| Apr 26, 2006 | Synthes (USA) Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. Terminated |
JEY | None listed |
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