The following data is part of a premarket notification filed by Eisertech, Llc with the FDA for Cervical Plate.
| Device ID | K113170 |
| 510k Number | K113170 |
| Device Name: | CERVICAL PLATE |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | EISERTECH, LLC 2555 FRONT STREET San Diego, CA 92103 |
| Contact | Lukas Eisermann |
| Correspondent | Lukas Eisermann EISERTECH, LLC 2555 FRONT STREET San Diego, CA 92103 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-27 |
| Decision Date | 2012-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B5231000460 | K113170 | 000 |
| B52310008736 | K113170 | 000 |
| B52310008838 | K113170 | 000 |
| B52310008840 | K113170 | 000 |
| B52310008842 | K113170 | 000 |
| B52310008844 | K113170 | 000 |
| B52310008846 | K113170 | 000 |
| B52310008848 | K113170 | 000 |
| B52310008850 | K113170 | 000 |
| B52310008852 | K113170 | 000 |
| B52310008954 | K113170 | 000 |
| B52310008957 | K113170 | 000 |
| B52310008960 | K113170 | 000 |
| B52310008963 | K113170 | 000 |
| B52310008966 | K113170 | 000 |
| B52310008734 | K113170 | 000 |
| B52310008732 | K113170 | 000 |
| B5231000570 | K113170 | 000 |
| B5231000650 | K113170 | 000 |
| B5231000750 | K113170 | 000 |
| B5231000780 | K113170 | 000 |
| B5231000793010 | K113170 | 000 |
| B5231000793012 | K113170 | 000 |
| B5231000793014 | K113170 | 000 |
| B5231000793016 | K113170 | 000 |
| B5231000860 | K113170 | 000 |
| B52310008722 | K113170 | 000 |
| B52310008724 | K113170 | 000 |
| B52310008726 | K113170 | 000 |
| B52310008728 | K113170 | 000 |
| B52310008730 | K113170 | 000 |
| B52310008969 | K113170 | 000 |
| B52310008972 | K113170 | 000 |
| B5231000934016 | K113170 | 000 |
| B5231000934510 | K113170 | 000 |
| B5231000934512 | K113170 | 000 |
| B5231000934514 | K113170 | 000 |
| B5231000934516 | K113170 | 000 |
| B5231000944010 | K113170 | 000 |
| B5231000944012 | K113170 | 000 |
| B5231000944014 | K113170 | 000 |
| B5231000944016 | K113170 | 000 |
| B5231000944510 | K113170 | 000 |
| B5231000944512 | K113170 | 000 |
| B5231000944514 | K113170 | 000 |
| B5231000944516 | K113170 | 000 |
| B5231001630 | K113170 | 000 |
| B5231000934014 | K113170 | 000 |
| B5231000934012 | K113170 | 000 |
| B52310008975 | K113170 | 000 |
| B52310008978 | K113170 | 000 |
| B523100090102 | K113170 | 000 |
| B523100090106 | K113170 | 000 |
| B523100090110 | K113170 | 000 |
| B52310009070 | K113170 | 000 |
| B52310009074 | K113170 | 000 |
| B52310009078 | K113170 | 000 |
| B52310009082 | K113170 | 000 |
| B52310009086 | K113170 | 000 |
| B52310009090 | K113170 | 000 |
| B52310009094 | K113170 | 000 |
| B52310009098 | K113170 | 000 |
| B5231000934010 | K113170 | 000 |
| B5231001670 | K113170 | 000 |