The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Loqteq Va Radius Set 2.5.
| Device ID | K153034 |
| 510k Number | K153034 |
| Device Name: | Aap LOQTEQ VA Radius Set 2.5 |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-19 |
| Decision Date | 2016-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409364112 | K153034 | 000 |
| 04042409363115 | K153034 | 000 |
| 04042409363108 | K153034 | 000 |
| 04042409363092 | K153034 | 000 |
| 04042409363085 | K153034 | 000 |
| 04042409363078 | K153034 | 000 |
| 04042409363061 | K153034 | 000 |
| 04042409363054 | K153034 | 000 |
| 04042409363047 | K153034 | 000 |
| 04042409363030 | K153034 | 000 |
| 04042409363023 | K153034 | 000 |
| 04042409363016 | K153034 | 000 |
| 04042409363009 | K153034 | 000 |
| 04042409362996 | K153034 | 000 |
| 04042409362989 | K153034 | 000 |
| 04042409363122 | K153034 | 000 |
| 04042409363139 | K153034 | 000 |
| 04042409363146 | K153034 | 000 |
| 04042409363306 | K153034 | 000 |
| 04042409363290 | K153034 | 000 |
| 04042409363283 | K153034 | 000 |
| 04042409363276 | K153034 | 000 |
| 04042409363269 | K153034 | 000 |
| 04042409363252 | K153034 | 000 |
| 04042409363221 | K153034 | 000 |
| 04042409363214 | K153034 | 000 |
| 04042409363207 | K153034 | 000 |
| 04042409363191 | K153034 | 000 |
| 04042409363184 | K153034 | 000 |
| 04042409363177 | K153034 | 000 |
| 04042409363160 | K153034 | 000 |
| 04042409363153 | K153034 | 000 |
| 04042409362972 | K153034 | 000 |