The following data is part of a premarket notification filed by Stork Instrumente Gmbh with the FDA for Bone Wire.
| Device ID | K030665 |
| 510k Number | K030665 |
| Device Name: | BONE WIRE |
| Classification | Pin, Fixation, Smooth |
| Applicant | STORK INSTRUMENTE GMBH 7046 BENTLY DR. Gurnee, IL 60031 |
| Contact | Lori Advids |
| Correspondent | Lori Advids STORK INSTRUMENTE GMBH 7046 BENTLY DR. Gurnee, IL 60031 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-03 |
| Decision Date | 2003-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840314241573 | K030665 | 000 |
| M7557921101 | K030665 | 000 |
| M7557921121 | K030665 | 000 |
| M7557921151 | K030665 | 000 |
| M7557921161 | K030665 | 000 |
| M7557921181 | K030665 | 000 |
| M7557923061 | K030665 | 000 |
| M7557923101 | K030665 | 000 |
| M7557923121 | K030665 | 000 |
| M7557921061 | K030665 | 000 |
| M7557923161 | K030665 | 000 |
| 00840314241672 | K030665 | 000 |
| 00840314241597 | K030665 | 000 |
| 00840314241603 | K030665 | 000 |
| 00840314241610 | K030665 | 000 |
| 00840314241627 | K030665 | 000 |
| 00840314241634 | K030665 | 000 |
| 00840314241641 | K030665 | 000 |
| 00840314241658 | K030665 | 000 |
| 00840314241665 | K030665 | 000 |
| M7557923151 | K030665 | 000 |
| M7557923181 | K030665 | 000 |
| M7557920020 | K030665 | 000 |
| M7557921120 | K030665 | 000 |
| M7557921150 | K030665 | 000 |
| M7557921160 | K030665 | 000 |
| M7557921180 | K030665 | 000 |
| M7557923060 | K030665 | 000 |
| M7557923100 | K030665 | 000 |
| M7557923120 | K030665 | 000 |
| M7557923150 | K030665 | 000 |
| M7557921100 | K030665 | 000 |
| M7557921060 | K030665 | 000 |
| M7557920150 | K030665 | 000 |
| M7557920040 | K030665 | 000 |
| M7557920050 | K030665 | 000 |
| M7557920060 | K030665 | 000 |
| M7557920070 | K030665 | 000 |
| M7557920080 | K030665 | 000 |
| M7557920090 | K030665 | 000 |
| M7557920100 | K030665 | 000 |
| M7557920120 | K030665 | 000 |
| M7557923160 | K030665 | 000 |