The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Cannulated Screw.
| Device ID | K130319 |
| 510k Number | K130319 |
| Device Name: | MEDLINE CANNULATED SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-08 |
| Decision Date | 2013-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193489024005 | K130319 | 000 |
| 10193489023992 | K130319 | 000 |
| 10193489023978 | K130319 | 000 |
| 10193489023961 | K130319 | 000 |
| 10193489023954 | K130319 | 000 |
| 10193489023947 | K130319 | 000 |
| 10193489023930 | K130319 | 000 |
| 10193489023923 | K130319 | 000 |
| 10193489023916 | K130319 | 000 |