The following data is part of a premarket notification filed by Depuy Mitek with the FDA for Double Armed Meniscal Needles With Size #2-0 Orthocord, Meniscal Needle With Wire Eyelet & 3 Free Strands Of Size #2-0.
| Device ID | K080918 |
| 510k Number | K080918 |
| Device Name: | DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0 |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | Depuy Mitek 325 Paramount Drive Raynham, MA 02767 |
| Contact | Kristine Christo |
| Correspondent | Kristine Christo Depuy Mitek 325 Paramount Drive Raynham, MA 02767 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-01 |
| Decision Date | 2008-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886705010070 | K080918 | 000 |
| 20886705010063 | K080918 | 000 |