The following data is part of a premarket notification filed by Pisharodi Surgicals, Inc. with the FDA for Simplex Cervical Fixation System.
| Device ID | K070335 |
| 510k Number | K070335 |
| Device Name: | SIMPLEX CERVICAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | PISHARODI SURGICALS, INC. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb PISHARODI SURGICALS, INC. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-05 |
| Decision Date | 2007-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852647007993 | K070335 | 000 |
| 00852647007764 | K070335 | 000 |
| 00852647007757 | K070335 | 000 |
| 00852647007740 | K070335 | 000 |
| 00852647007733 | K070335 | 000 |
| 00852647007726 | K070335 | 000 |
| 00852647007719 | K070335 | 000 |
| 00852647007702 | K070335 | 000 |
| 00852647007696 | K070335 | 000 |
| 00852647007689 | K070335 | 000 |
| 00852647007672 | K070335 | 000 |
| 00852647007665 | K070335 | 000 |
| 00852647007658 | K070335 | 000 |
| 00852647007641 | K070335 | 000 |
| 00852647007634 | K070335 | 000 |
| 00852647007627 | K070335 | 000 |
| 00852647007610 | K070335 | 000 |
| 00852647007771 | K070335 | 000 |
| 00852647007788 | K070335 | 000 |
| 00852647007795 | K070335 | 000 |
| 00852647007986 | K070335 | 000 |
| 00852647007948 | K070335 | 000 |
| 00852647007931 | K070335 | 000 |
| 00852647007924 | K070335 | 000 |
| 00852647007917 | K070335 | 000 |
| 00852647007900 | K070335 | 000 |
| 00852647007894 | K070335 | 000 |
| 00852647007887 | K070335 | 000 |
| 00852647007870 | K070335 | 000 |
| 00852647007863 | K070335 | 000 |
| 00852647007856 | K070335 | 000 |
| 00852647007849 | K070335 | 000 |
| 00852647007832 | K070335 | 000 |
| 00852647007825 | K070335 | 000 |
| 00852647007818 | K070335 | 000 |
| 00852647007801 | K070335 | 000 |
| 00852647007603 | K070335 | 000 |