The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus V-lox Peek Cf Suture Anchor, Models: 10253, 10254, 10263, 10264.
| Device ID | K091094 |
| 510k Number | K091094 |
| Device Name: | PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| 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 |
|---|---|---|
| M68510325T0 | K091094 | 000 |
| 00816342024198 | K091094 | 000 |
| 00816342020992 | K091094 | 000 |
| 00816342021005 | K091094 | 000 |
| 00816342022125 | K091094 | 000 |
| 00816342022132 | K091094 | 000 |
| 00816342022170 | K091094 | 000 |
| 00816342022187 | K091094 | 000 |
| 00816342023849 | K091094 | 000 |
| M685102530 | K091094 | 000 |
| M68510253T0 | K091094 | 000 |
| M68510254T0 | K091094 | 000 |
| M685102630 | K091094 | 000 |
| M685102631 | K091094 | 000 |
| M685102640 | K091094 | 000 |
| M685102641 | K091094 | 000 |
| M68510324T0 | K091094 | 000 |
| 00816342024181 | K091094 | 000 |