The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Birmingham Hip (bh) Dual Mobility Insert.
| Device ID | K171934 |
| 510k Number | K171934 |
| Device Name: | Birmingham Hip (BH) Dual Mobility Insert |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Mike Scott |
| Correspondent | Mike Scott Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-28 |
| Decision Date | 2017-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556577509 | K171934 | 000 |
| 00885556577271 | K171934 | 000 |
| 00885556577264 | K171934 | 000 |
| 00885556577257 | K171934 | 000 |
| 00885556577240 | K171934 | 000 |
| 00885556577233 | K171934 | 000 |
| 00885556577226 | K171934 | 000 |
| 00885556577219 | K171934 | 000 |
| 00885556577202 | K171934 | 000 |
| 00885556577196 | K171934 | 000 |
| 00885556577288 | K171934 | 000 |
| 00885556577400 | K171934 | 000 |
| 00885556577493 | K171934 | 000 |
| 00885556577486 | K171934 | 000 |
| 00885556577479 | K171934 | 000 |
| 00885556577462 | K171934 | 000 |
| 00885556577455 | K171934 | 000 |
| 00885556577448 | K171934 | 000 |
| 00885556577431 | K171934 | 000 |
| 00885556577424 | K171934 | 000 |
| 00885556577417 | K171934 | 000 |
| 00885556577189 | K171934 | 000 |