The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for 3m Modular Shoulder System.
| Device ID | K920362 |
| 510k Number | K920362 |
| Device Name: | 3M MODULAR SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Contact | Willard D Larson |
| Correspondent | Willard D Larson 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-28 |
| Decision Date | 1993-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010398888 | K920362 | 000 |
| 03596010398536 | K920362 | 000 |
| 03596010398390 | K920362 | 000 |
| 03596010398413 | K920362 | 000 |
| 03596010398420 | K920362 | 000 |
| 03596010398543 | K920362 | 000 |
| 03596010398567 | K920362 | 000 |
| 03596010398581 | K920362 | 000 |
| 03596010398598 | K920362 | 000 |
| 03596010398611 | K920362 | 000 |
| 03596010398741 | K920362 | 000 |
| 03596010398772 | K920362 | 000 |
| 03596010398796 | K920362 | 000 |
| 03596010398819 | K920362 | 000 |
| 03596010398833 | K920362 | 000 |
| 03596010398864 | K920362 | 000 |
| 03596010398444 | K920362 | 000 |