The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Souter Strathclyde Total Elbow System.
| Device ID | K880188 |
| 510k Number | K880188 |
| Device Name: | SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Robert E Smith |
| Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDB |
| CFR Regulation Number | 888.3160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-15 |
| Decision Date | 1988-03-01 |