Panels › General, Plastic Surgery › Product code LRZ · Class 1
Screwdriver, Surgical
Regulation 878.4800
0510(k)s in 12 months (3 all time)
0recalls in 12 months (6 all time)
1recalls that name a 510(k)
Top companies in LRZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Aesculap, Inc. | 0 | 4 |
| Genesys Orthopedics Systems, LLC | 0 | 1 |
| Integra LifeSciences Corp. | 0 | 1 |
| Med-Tool, Inc. | 1 | 0 |
| Micro-Aire Surgical Instruments, Inc. | 1 | 0 |
| Optik | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2015 | Aesculap, Inc. Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed.
These instr Terminated |
LRZ | None listed |
| Dec 16, 2015 | Aesculap, Inc. Flexible Drill;
SJ723R; NON STERILE;
B Braun Aesculap;
Aesculap AG
These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Terminated |
LRZ | None listed |
| Dec 16, 2015 | Aesculap, Inc. Flexible Bone Awl;
SJ607R; NON STERILE;
B Braun Aesculap;
Aesculap AG:
These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Terminated |
LRZ | None listed |
| Dec 16, 2015 | Aesculap, Inc. Flexible Screw Driver SJ706R;
Non Sterile;
B Braun;
Aesculap;
Aesculap AG
These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Terminated |
LRZ | None listed |
| Nov 5, 2015 | Genesys Orthopedics Systems, LLC Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System
The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation Terminated |
LRZ | K133245 |
| Jul 11, 2013 | Integra LifeSciences Corp. Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND).
Indicated for use in fixation of fractures, osteotomies and arthrodes Terminated |
LRZ | None listed |
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