The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Solar Shoulder Offset Humeral Head.
| Device ID | K001419 |
| 510k Number | K001419 |
| Device Name: | SOLAR SHOULDER OFFSET HUMERAL HEAD |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-05 |
| Decision Date | 2000-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327139778 | K001419 | 000 |
| 07613327138085 | K001419 | 000 |
| 07613327138108 | K001419 | 000 |
| 07613327138122 | K001419 | 000 |
| 07613327138139 | K001419 | 000 |
| 07613327138146 | K001419 | 000 |
| 07613327138184 | K001419 | 000 |
| 07613327138313 | K001419 | 000 |
| 07613327139600 | K001419 | 000 |
| 07613327139617 | K001419 | 000 |
| 07613327139624 | K001419 | 000 |
| 07613327139631 | K001419 | 000 |
| 07613327139648 | K001419 | 000 |
| 07613327139655 | K001419 | 000 |
| 07613327139723 | K001419 | 000 |
| 07613327138047 | K001419 | 000 |