The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus V-lox Titanium Suture Anchor,models: 10251, 10252, 10257, 10258.
| Device ID | K090075 |
| 510k Number | K090075 |
| Device Name: | PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 |
| 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 | 2009-01-12 |
| Decision Date | 2009-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M68510358T0 | K090075 | 000 |
| 00816342020985 | K090075 | 000 |
| 00816342021012 | K090075 | 000 |
| 00816342021067 | K090075 | 000 |
| 00816342022118 | K090075 | 000 |
| 00816342022149 | K090075 | 000 |
| 00816342022156 | K090075 | 000 |
| 00816342022200 | K090075 | 000 |
| 00816342022217 | K090075 | 000 |
| 00816342022224 | K090075 | 000 |
| 00816342021029 | K090075 | 000 |
| M685102510 | K090075 | 000 |
| M68510252T0 | K090075 | 000 |
| M685102570 | K090075 | 000 |
| M685102580 | K090075 | 000 |
| M68510284T0 | K090075 | 000 |
| M68510353T0 | K090075 | 000 |
| M68510356T0 | K090075 | 000 |
| 00816342020978 | K090075 | 000 |