The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Cross Cancellous Bone Screw.
Device ID | K896044 |
510k Number | K896044 |
Device Name: | CROSS CANCELLOUS BONE SCREW |
Classification | Screw, Fixation, Bone |
Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | Bromme, Rn |
Correspondent | Bromme, Rn BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-17 |
Decision Date | 1989-11-09 |