The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Acromed Spinal Surgery Instruments.
Device ID | K860131 |
510k Number | K860131 |
Device Name: | ACROMED SPINAL SURGERY INSTRUMENTS |
Classification | Orthopedic Manual Surgical Instrument |
Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David Schlerf |
Correspondent | David Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | LXH |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-14 |
Decision Date | 1986-03-19 |