The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Taylor Spinal Retractor.
Device ID | K892546 |
510k Number | K892546 |
Device Name: | TAYLOR SPINAL RETRACTOR |
Classification | Instrument, Surgical, Non-powered |
Applicant | ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
Contact | Anna Straight |
Correspondent | Anna Straight ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
Product Code | HAO |
CFR Regulation Number | 882.4535 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-11 |
Decision Date | 1989-05-11 |