The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Cortical Screw 1.5, Self-tapping, Aap Cortical Screw 1.5, Self-tapping, Titanium.
| Device ID | K150974 |
| 510k Number | K150974 |
| Device Name: | Aap Cortical Screw 1.5, Self-tapping, Aap Cortical Screw 1.5, Self-tapping, Titanium |
| Classification | Screw, Fixation, Bone |
| Applicant | AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE D-12099 |
| Contact | Christian Zietsch |
| Correspondent | Christian Zietsch AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE D-12099 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-13 |
| Decision Date | 2015-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409192548 | K150974 | 000 |
| 04042409192388 | K150974 | 000 |
| 04042409192371 | K150974 | 000 |
| 04042409192364 | K150974 | 000 |
| 04042409192357 | K150974 | 000 |
| 04042409192340 | K150974 | 000 |
| 04042409192333 | K150974 | 000 |
| 04042409192326 | K150974 | 000 |
| 04042409192302 | K150974 | 000 |
| 04042409192289 | K150974 | 000 |
| 04042409192227 | K150974 | 000 |
| 04042409192395 | K150974 | 000 |
| 04042409192418 | K150974 | 000 |
| 04042409192531 | K150974 | 000 |
| 04042409192517 | K150974 | 000 |
| 04042409192500 | K150974 | 000 |
| 04042409192494 | K150974 | 000 |
| 04042409192487 | K150974 | 000 |
| 04042409192470 | K150974 | 000 |
| 04042409192463 | K150974 | 000 |
| 04042409192449 | K150974 | 000 |
| 04042409192432 | K150974 | 000 |
| 04042409192425 | K150974 | 000 |
| 04042409192203 | K150974 | 000 |