The following data is part of a premarket notification filed by Regeneration Technologies, Inc. with the FDA for Sterling Interferenc Screw Ht.
| Device ID | K052405 |
| 510k Number | K052405 |
| Device Name: | STERLING INTERFERENC SCREW HT |
| Classification | Screw, Fixation, Bone |
| Applicant | REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua, FL 32616 -2650 |
| Contact | Carrie Hartill |
| Correspondent | Carrie Hartill REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua, FL 32616 -2650 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-01 |
| Decision Date | 2005-11-16 |
| Summary: | summary |