The following data is part of a premarket notification filed by Depuy Mitek with the FDA for Panalok Rc Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok Rc Quickanchor Pllus, Models 212132, 212732.
| Device ID | K041117 |
| 510k Number | K041117 |
| Device Name: | PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 |
| Classification | Staple, Fixation, Bone |
| Applicant | Depuy Mitek 249 VANDERBILT DR. Norwood, MA 02062 |
| Contact | Allyson Barford |
| Correspondent | Allyson Barford Depuy Mitek 249 VANDERBILT DR. Norwood, MA 02062 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-29 |
| Decision Date | 2004-05-28 |
| Summary: | summary |