The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Bioabsorbable Interference Screw Megafix.
| Device ID | K013107 |
| 510k Number | K013107 |
| Device Name: | BIOABSORBABLE INTERFERENCE SCREW MEGAFIX |
| Classification | Screw, Fixation, Bone |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | James A Lee |
| Correspondent | James A Lee KARL STORZ ENDOSCOPY 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 | 2001-09-17 |
| Decision Date | 2002-02-26 |
| Summary: | summary |