The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus Ppek Cf Interference Screw.
| Device ID | K091093 |
| 510k Number | K091093 |
| Device Name: | PARCUS PPEK CF INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. Sturgeon Bay, WI 54235 |
| Contact | Barton Bracy |
| Correspondent | Barton Bracy PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. Sturgeon Bay, WI 54235 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-16 |
| Decision Date | 2009-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816342020855 | K091093 | 000 |
| 00816342020268 | K091093 | 000 |
| 00816342020251 | K091093 | 000 |
| 00816342020244 | K091093 | 000 |
| 00816342020237 | K091093 | 000 |
| 00816342020220 | K091093 | 000 |
| 00816342020213 | K091093 | 000 |
| 00816342020206 | K091093 | 000 |
| 00816342020190 | K091093 | 000 |
| 00816342020275 | K091093 | 000 |
| 00816342020282 | K091093 | 000 |
| 00816342020299 | K091093 | 000 |
| 00816342020848 | K091093 | 000 |
| 00816342020831 | K091093 | 000 |
| 00816342020350 | K091093 | 000 |
| 00816342020343 | K091093 | 000 |
| 00816342020336 | K091093 | 000 |
| 00816342020329 | K091093 | 000 |
| 00816342020312 | K091093 | 000 |
| 00816342020305 | K091093 | 000 |
| 00816342020183 | K091093 | 000 |