The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Modification To Tenor Spinal System-rod/bolt Connector.
| Device ID | K991528 |
| 510k Number | K991528 |
| Device Name: | MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis, TN 38132 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 1999-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490881753 | K991528 | 000 |
| 00673978037202 | K991528 | 000 |
| 00673978037196 | K991528 | 000 |
| 00673978037189 | K991528 | 000 |
| 00673978037172 | K991528 | 000 |
| 00673978037165 | K991528 | 000 |
| 00673978037158 | K991528 | 000 |
| 00673978037141 | K991528 | 000 |
| 00673978037110 | K991528 | 000 |
| 00673978037097 | K991528 | 000 |
| 00673978037080 | K991528 | 000 |
| 00673978037073 | K991528 | 000 |
| 00673978037066 | K991528 | 000 |
| 00673978037219 | K991528 | 000 |
| 00673978037226 | K991528 | 000 |
| 00681490881746 | K991528 | 000 |
| 00673978971063 | K991528 | 000 |
| 00673978971056 | K991528 | 000 |
| 00673978971049 | K991528 | 000 |
| 00673978971032 | K991528 | 000 |
| 00673978049137 | K991528 | 000 |
| 00673978037288 | K991528 | 000 |
| 00673978037271 | K991528 | 000 |
| 00673978037264 | K991528 | 000 |
| 00673978037257 | K991528 | 000 |
| 00673978037240 | K991528 | 000 |
| 00673978037233 | K991528 | 000 |
| 00673978037059 | K991528 | 000 |