The following data is part of a premarket notification filed by Immedica, Inc. with the FDA for External Fixation Anchor Pin.
| Device ID | K001228 |
| 510k Number | K001228 |
| Device Name: | EXTERNAL FIXATION ANCHOR PIN |
| Classification | Pin, Fixation, Threaded |
| Applicant | IMMEDICA, INC. 100 PASSAIC AVE. Chatham, NJ 07928 -2848 |
| Contact | Roy Bogert |
| Correspondent | Roy Bogert IMMEDICA, INC. 100 PASSAIC AVE. Chatham, NJ 07928 -2848 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-17 |
| Decision Date | 2000-07-07 |