The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Quickset Mimix Bone Void Filler.
| Device ID | K023718 |
| 510k Number | K023718 |
| Device Name: | QUICKSET MIMIX BONE VOID FILLER |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | WALTER LORENZ SURGICAL, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 |
| Contact | Kacy Arnold |
| Correspondent | Kacy Arnold WALTER LORENZ SURGICAL, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-05 |
| Decision Date | 2002-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036020828 | K023718 | 000 |
| 00841036020811 | K023718 | 000 |