The following data is part of a premarket notification filed by Cadwell Lab, Inc. with the FDA for Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /ball Tip Pedicle Screw Stimulator Probe,.
| Device ID | K103128 |
| 510k Number | K103128 |
| Device Name: | CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, |
| Classification | Stimulator, Nerve |
| Applicant | CADWELL LAB, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Chris L Bolkan |
| Correspondent | Chris L Bolkan CADWELL LAB, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-25 |
| Decision Date | 2011-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840067101759 | K103128 | 000 |
| 10840067101824 | K103128 | 000 |
| 00840067101810 | K103128 | 000 |
| 00840067101803 | K103128 | 000 |
| 00840067101797 | K103128 | 000 |
| 00840067101780 | K103128 | 000 |
| 00840067101773 | K103128 | 000 |
| 00840067101766 | K103128 | 000 |
| 00840067101742 | K103128 | 000 |
| 00840067101735 | K103128 | 000 |
| 10840067100797 | K103128 | 000 |
| 10840067101831 | K103128 | 000 |
| 10840067101848 | K103128 | 000 |
| 10840067101855 | K103128 | 000 |
| 00840067101728 | K103128 | 000 |
| 00840067101711 | K103128 | 000 |
| 00840067101704 | K103128 | 000 |
| 00840067101698 | K103128 | 000 |
| 00840067102480 | K103128 | 000 |
| 00840067101902 | K103128 | 000 |
| 10840067101893 | K103128 | 000 |
| 10840067101886 | K103128 | 000 |
| 10840067101879 | K103128 | 000 |
| 10840067101862 | K103128 | 000 |
| 10840067100025 | K103128 | 000 |