The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Fixation (steinmann) Pins.
| Device ID | K013888 |
| 510k Number | K013888 |
| Device Name: | FIXATION (STEINMANN) PINS |
| Classification | Pin, Fixation, Smooth |
| Applicant | MILTEX, INC. 700 HICKSVILLE RD. Bethpage, NY 11714 |
| Contact | Richard Gordon |
| Correspondent | Richard Gordon MILTEX, INC. 700 HICKSVILLE RD. Bethpage, NY 11714 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2002-05-01 |
| Summary: | summary |