The following data is part of a premarket notification filed by Aap Gmbh And Co. Betriebs Kg with the FDA for Biorigid Nail Tibia.
| Device ID | K970013 |
| 510k Number | K970013 |
| Device Name: | BIORIGID NAIL TIBIA |
| Classification | Pin, Fixation, Smooth |
| Applicant | AAP GMBH AND CO. BETRIEBS KG LORENZWEG 5 12099 Berlin, DE D-1000 |
| Contact | Dipl.-ing Christian Abel |
| Correspondent | Dipl.-ing Christian Abel AAP GMBH AND CO. BETRIEBS KG LORENZWEG 5 12099 Berlin, DE D-1000 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-02 |
| Decision Date | 1997-03-13 |