The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Megafix-t Titanium Interference Screw.
| Device ID | K030368 |
| 510k Number | K030368 |
| Device Name: | KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE 5TH FLOOR Culver City, CA 90230 -7600 |
| Contact | Mario T Marcelo |
| Correspondent | Mario T Marcelo KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE 5TH FLOOR Culver City, CA 90230 -7600 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-04 |
| Decision Date | 2003-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551112649 | K030368 | 000 |