Panels › Orthopedic › Product code NDJ · Class 2
Screw, Fixation, Bone, Non-Spinal, Metallic
Regulation 888.3040
0510(k)s in 12 months (0 all time)
0recalls in 12 months (13 all time)
2recalls that name a 510(k)
Top companies in NDJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Inc. | 0 | 11 |
| Biomet Microfixation, Inc. | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2015 | Zimmer, Inc. Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device. Terminated |
NDJ | None listed |
| Feb 20, 2014 | Zimmer, Inc. INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG
Some items starting with codes 0022530 Terminated |
NDJ | None listed |
| Jan 23, 2012 | Biomet Microfixation, Inc. Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE Terminated |
NDJ | K953385 |
| Jan 23, 2012 | Biomet Microfixation, Inc. Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE Terminated |
NDJ | K953385 |
| Aug 3, 2006 | Zimmer Inc. Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head, 100 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-100-55 (00225310055). Terminated |
NDJ | None listed |
| Aug 3, 2006 | Zimmer Inc. Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head, 95 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-95-55 (00225309555). Terminated |
NDJ | None listed |
| Aug 3, 2006 | Zimmer Inc. Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 85 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-85-42 (00225308542). Terminated |
NDJ | None listed |
| Aug 3, 2006 | Zimmer Inc. Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 75 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-75-42 (00225307542). Terminated |
NDJ | None listed |
| Aug 3, 2006 | Zimmer Inc. Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head, 70 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-70-55 (00225307055). Terminated |
NDJ | None listed |
| Aug 3, 2006 | Zimmer Inc. Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 70 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-70-42 (00225307042). Terminated |
NDJ | None listed |
| Aug 3, 2006 | Zimmer Inc. Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 65 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-65-45 (00225306545). Terminated |
NDJ | None listed |
| Aug 3, 2006 | Zimmer Inc. Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 55 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-55-45 (00225305545). Terminated |
NDJ | None listed |
| Aug 3, 2006 | Zimmer Inc. Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 52.5 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-53-45 (00225305345). Terminated |
NDJ | None listed |
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