The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Hydroxyapatite (ha) Reflection Acetabular Shell, Hydroxyapatite (ha) Reflection Interfit Shell.
| Device ID | K990666 |
| 510k Number | K990666 |
| Device Name: | HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Janet Johnson Green |
| Correspondent | Janet Johnson Green SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-02 |
| Decision Date | 1999-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556021422 | K990666 | 000 |
| 03596010452764 | K990666 | 000 |
| 03596010452757 | K990666 | 000 |
| 03596010452740 | K990666 | 000 |
| 03596010452733 | K990666 | 000 |
| 03596010452726 | K990666 | 000 |
| 03596010452719 | K990666 | 000 |
| 03596010452702 | K990666 | 000 |
| 03596010452856 | K990666 | 000 |
| 03596010452849 | K990666 | 000 |
| 03596010452832 | K990666 | 000 |
| 03596010452825 | K990666 | 000 |
| 03596010452818 | K990666 | 000 |
| 03596010452801 | K990666 | 000 |
| 03596010452771 | K990666 | 000 |
| 03596010452696 | K990666 | 000 |
| 03596010468239 | K990666 | 000 |
| 03596010463326 | K990666 | 000 |
| 03596010452788 | K990666 | 000 |
| 03596010452795 | K990666 | 000 |
| 00885556020722 | K990666 | 000 |
| 00885556020005 | K990666 | 000 |
| 00885556019740 | K990666 | 000 |
| 03596010647702 | K990666 | 000 |
| 03596010647696 | K990666 | 000 |
| 03596010463333 | K990666 | 000 |
| 03596010463302 | K990666 | 000 |
| 03596010463296 | K990666 | 000 |
| 03596010463289 | K990666 | 000 |
| 03596010462695 | K990666 | 000 |
| 03596010460479 | K990666 | 000 |
| 03596010460462 | K990666 | 000 |
| 03596010460455 | K990666 | 000 |
| 03596010460448 | K990666 | 000 |
| 03596010454225 | K990666 | 000 |
| 03596010454218 | K990666 | 000 |
| 03596010452863 | K990666 | 000 |
| 03596010463319 | K990666 | 000 |