The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Div. with the FDA for Plc Suture Anchor.
| Device ID | K063726 |
| 510k Number | K063726 |
| Device Name: | PLC SUTURE ANCHOR |
| Classification | Plate, Fixation, Bone |
| Applicant | SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Deana Boushell |
| Correspondent | Deana Boushell SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-15 |
| Decision Date | 2007-03-06 |
| Summary: | summary |