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 |