The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Cofield Eccentric And Lateral Offset Humeral Heads.
| Device ID | K003566 |
| 510k Number | K003566 |
| Device Name: | COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-20 |
| Decision Date | 2001-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556048184 | K003566 | 000 |
| 03596010464453 | K003566 | 000 |
| 03596010464606 | K003566 | 000 |
| 03596010464590 | K003566 | 000 |
| 03596010464583 | K003566 | 000 |
| 03596010464576 | K003566 | 000 |
| 03596010464569 | K003566 | 000 |
| 03596010464552 | K003566 | 000 |
| 03596010464545 | K003566 | 000 |
| 03596010464460 | K003566 | 000 |
| 03596010464477 | K003566 | 000 |
| 00885556047941 | K003566 | 000 |
| 00885556047729 | K003566 | 000 |
| 03596010465665 | K003566 | 000 |
| 03596010464521 | K003566 | 000 |
| 03596010464514 | K003566 | 000 |
| 03596010464507 | K003566 | 000 |
| 03596010464491 | K003566 | 000 |
| 03596010464484 | K003566 | 000 |
| 03596010464538 | K003566 | 000 |