The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020.
| Device ID | K083619 |
| 510k Number | K083619 |
| Device Name: | PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 |
| 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 | 2008-12-08 |
| Decision Date | 2009-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816342020145 | K083619 | 000 |
| 00816342020039 | K083619 | 000 |
| 00816342020046 | K083619 | 000 |
| 00816342020053 | K083619 | 000 |
| 00816342020060 | K083619 | 000 |
| 00816342020077 | K083619 | 000 |
| 00816342020084 | K083619 | 000 |
| 00816342020091 | K083619 | 000 |
| 00816342020107 | K083619 | 000 |
| 00816342020114 | K083619 | 000 |
| 00816342020121 | K083619 | 000 |
| 00816342020138 | K083619 | 000 |
| 00816342020152 | K083619 | 000 |
| 00816342020169 | K083619 | 000 |
| 00816342020176 | K083619 | 000 |
| 00816342020800 | K083619 | 000 |
| 00816342020817 | K083619 | 000 |
| 00816342020824 | K083619 | 000 |
| 00816342020022 | K083619 | 000 |