The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Megafix-c Bioabsorbable Composite Interference Screw, Model 2870719c, 2870723c, 2870823c, 2870828c, 2870928c.
| Device ID | K071437 |
| 510k Number | K071437 |
| Device Name: | MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C |
| Classification | Screw, Fixation, Bone |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Crystal Dizol |
| Correspondent | Crystal Dizol KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE 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 | 2007-05-23 |
| Decision Date | 2007-09-12 |
| Summary: | summary |