The following data is part of a premarket notification filed by Regeneration Technologies, Inc. with the FDA for Sterling If Screw Eyelet, Model Cid3936 And Sterling Cross-pin Eyelet, Model Cid3937.
| Device ID | K063584 |
| 510k Number | K063584 |
| Device Name: | STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 |
| Classification | Screw, Fixation, Bone |
| Applicant | REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua, FL 32616 -2650 |
| Contact | Lisa Simpson |
| Correspondent | Lisa Simpson 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 | 2006-12-01 |
| Decision Date | 2007-05-09 |
| Summary: | summary |