The following data is part of a premarket notification filed by Smith & Nephew, Inc., Orthopaedic Div. with the FDA for Opera Cupflanged Acetabular Components.
| Device ID | K991538 |
| 510k Number | K991538 |
| Device Name: | OPERA CUPFLANGED ACETABULAR COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Janet Johnson Green |
| Correspondent | Janet Johnson Green SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 1999-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010380357 | K991538 | 000 |
| 03596010244819 | K991538 | 000 |
| 03596010244826 | K991538 | 000 |
| 03596010244833 | K991538 | 000 |
| 03596010380050 | K991538 | 000 |
| 03596010380067 | K991538 | 000 |
| 03596010380074 | K991538 | 000 |
| 03596010380081 | K991538 | 000 |
| 03596010380098 | K991538 | 000 |
| 03596010380104 | K991538 | 000 |
| 03596010380111 | K991538 | 000 |
| 03596010380128 | K991538 | 000 |
| 03596010380142 | K991538 | 000 |
| 03596010380234 | K991538 | 000 |
| 03596010380241 | K991538 | 000 |
| 03596010244802 | K991538 | 000 |