The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Reflection Modified Acetabular Shells.
| Device ID | K022556 |
| 510k Number | K022556 |
| Device Name: | REFLECTION MODIFIED ACETABULAR SHELLS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Kim Kelly |
| Correspondent | Kim Kelly SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-02 |
| Decision Date | 2002-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010535849 | K022556 | 000 |
| 03596010507112 | K022556 | 000 |
| 03596010507051 | K022556 | 000 |
| 03596010507037 | K022556 | 000 |
| 03596010001481 | K022556 | 000 |
| 03596010507150 | K022556 | 000 |
| 03596010507143 | K022556 | 000 |
| 03596010507136 | K022556 | 000 |
| 03596010507129 | K022556 | 000 |
| 03596010507105 | K022556 | 000 |
| 03596010507099 | K022556 | 000 |
| 03596010507082 | K022556 | 000 |
| 03596010507075 | K022556 | 000 |
| 03596010507068 | K022556 | 000 |
| 03596010507044 | K022556 | 000 |
| 03596010507020 | K022556 | 000 |
| 03596010488190 | K022556 | 000 |
| 03596010507167 | K022556 | 000 |
| 03596010507174 | K022556 | 000 |
| 03596010535832 | K022556 | 000 |
| 03596010535825 | K022556 | 000 |
| 03596010535818 | K022556 | 000 |
| 03596010535801 | K022556 | 000 |
| 03596010535795 | K022556 | 000 |
| 03596010535788 | K022556 | 000 |
| 03596010535771 | K022556 | 000 |
| 03596010535764 | K022556 | 000 |
| 03596010507259 | K022556 | 000 |
| 03596010507242 | K022556 | 000 |
| 03596010507235 | K022556 | 000 |
| 03596010507228 | K022556 | 000 |
| 03596010507211 | K022556 | 000 |
| 03596010507204 | K022556 | 000 |
| 03596010507198 | K022556 | 000 |
| 03596010507181 | K022556 | 000 |
| 03596010488183 | K022556 | 000 |