The following data is part of a premarket notification filed by Darco International, Inc. with the FDA for Darco Force Titanium Compression Screw.
| Device ID | K062103 |
| 510k Number | K062103 |
| Device Name: | DARCO FORCE TITANIUM COMPRESSION SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | DARCO INTERNATIONAL, INC. 810 MEMORIAL BLVD. Huntington, WV 25701 |
| Contact | Mark S Cooper |
| Correspondent | Mark S Cooper DARCO INTERNATIONAL, INC. 810 MEMORIAL BLVD. Huntington, WV 25701 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2006-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420111432 | K062103 | 000 |
| 00840420106834 | K062103 | 000 |
| 00840420106827 | K062103 | 000 |
| 00840420106810 | K062103 | 000 |
| 00840420106803 | K062103 | 000 |
| 00840420106797 | K062103 | 000 |
| 00840420106780 | K062103 | 000 |
| 00840420136923 | K062103 | 000 |
| 00840420131690 | K062103 | 000 |
| 00840420131683 | K062103 | 000 |
| 00840420106841 | K062103 | 000 |
| 00840420106858 | K062103 | 000 |
| 00840420111425 | K062103 | 000 |
| 00840420111418 | K062103 | 000 |
| 00840420111401 | K062103 | 000 |
| 00840420111395 | K062103 | 000 |
| 00840420111388 | K062103 | 000 |
| 00840420106896 | K062103 | 000 |
| 00840420106889 | K062103 | 000 |
| 00840420106872 | K062103 | 000 |
| 00840420106865 | K062103 | 000 |
| 00840420131676 | K062103 | 000 |