The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Acromed Cancellous Bone Screw.
Device ID | K875053 |
510k Number | K875053 |
Device Name: | ACROMED CANCELLOUS BONE SCREW |
Classification | Screw, Fixation, Bone |
Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David W Schlerf |
Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-09 |
Decision Date | 1988-01-20 |