The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lactosorb Craniofacial Anchor-push Screw.
| Device ID | K013557 |
| 510k Number | K013557 |
| Device Name: | LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | WALTER LORENZ SURGICAL, INC. P.O. BOX 587 Warsaw,, IN 46581 -0578 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel WALTER LORENZ SURGICAL, INC. P.O. BOX 587 Warsaw,, IN 46581 -0578 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-24 |
| Decision Date | 2001-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036055332 | K013557 | 000 |
| 00841036055318 | K013557 | 000 |