The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Loqteq Large Fragment Set Loqteq Cortical Screw 4.5, Small Head, T25, Self Tapping Loqteq Cortical Screw 4.5, T25, Self.
| Device ID | K113648 |
| 510k Number | K113648 |
| Device Name: | LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF |
| 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 | 2011-12-12 |
| Decision Date | 2012-09-06 |
| Summary: | summary |