The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Hsc Unit Rod.
| Device ID | K896603 |
| 510k Number | K896603 |
| Device Name: | HSC UNIT ROD |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Contact | Frank M Lewis |
| Correspondent | Frank M Lewis DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-21 |
| Decision Date | 1990-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978050331 | K896603 | 000 |
| 00673978050072 | K896603 | 000 |
| 00673978050089 | K896603 | 000 |
| 00673978050096 | K896603 | 000 |
| 00673978050102 | K896603 | 000 |
| 00673978050119 | K896603 | 000 |
| 00673978050126 | K896603 | 000 |
| 00673978050133 | K896603 | 000 |
| 00673978050140 | K896603 | 000 |
| 00673978050157 | K896603 | 000 |
| 00673978050256 | K896603 | 000 |
| 00673978050263 | K896603 | 000 |
| 00673978050270 | K896603 | 000 |
| 00673978050287 | K896603 | 000 |
| 00673978050294 | K896603 | 000 |
| 00673978050300 | K896603 | 000 |
| 00673978050317 | K896603 | 000 |
| 00673978050324 | K896603 | 000 |
| 00673978050065 | K896603 | 000 |