The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Loqteq Proximal Humerus Plate 3.5, Short Loqteq Proximal Humerus Plate 3.5, Long.
| Device ID | K121495 |
| 510k Number | K121495 |
| Device Name: | LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG |
| Classification | Plate, Fixation, Bone |
| Applicant | AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
| Contact | Marc Seegers |
| Correspondent | Marc Seegers AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-21 |
| Decision Date | 2012-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409256714 | K121495 | 000 |
| 04042409234064 | K121495 | 000 |
| 04042409234057 | K121495 | 000 |
| 04042409234040 | K121495 | 000 |
| 04042409234033 | K121495 | 000 |
| 04042409234026 | K121495 | 000 |
| 04042409234019 | K121495 | 000 |
| 04042409234002 | K121495 | 000 |
| 04042409233999 | K121495 | 000 |
| 04042409233982 | K121495 | 000 |
| 04042409233975 | K121495 | 000 |
| 04042409234071 | K121495 | 000 |
| 04042409234088 | K121495 | 000 |
| 04042409234187 | K121495 | 000 |
| 04042409234170 | K121495 | 000 |
| 04042409234163 | K121495 | 000 |
| 04042409234156 | K121495 | 000 |
| 04042409234149 | K121495 | 000 |
| 04042409234132 | K121495 | 000 |
| 04042409234125 | K121495 | 000 |
| 04042409234118 | K121495 | 000 |
| 04042409234101 | K121495 | 000 |
| 04042409234095 | K121495 | 000 |
| 04042409233968 | K121495 | 000 |