The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Hip System.
| Device ID | K022902 |
| 510k Number | K022902 |
| Device Name: | SMITH & NEPHEW HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | David Henley |
| Correspondent | David Henley 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 | 2002-09-03 |
| Decision Date | 2002-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010479723 | K022902 | 000 |
| 03596010480019 | K022902 | 000 |
| 03596010480477 | K022902 | 000 |
| 03596010482815 | K022902 | 000 |
| 03596010482822 | K022902 | 000 |
| 03596010482839 | K022902 | 000 |
| 03596010531971 | K022902 | 000 |
| 03596010542472 | K022902 | 000 |
| 03596010552921 | K022902 | 000 |
| 03596010479792 | K022902 | 000 |
| 03596010479754 | K022902 | 000 |
| 03596010479747 | K022902 | 000 |
| 03596010479730 | K022902 | 000 |
| 03596010479761 | K022902 | 000 |
| 03596010479778 | K022902 | 000 |
| 03596010479785 | K022902 | 000 |
| 03596010479976 | K022902 | 000 |
| 03596010479983 | K022902 | 000 |
| 03596010479990 | K022902 | 000 |
| 03596010480002 | K022902 | 000 |
| 03596010552938 | K022902 | 000 |
| 03596010552945 | K022902 | 000 |
| 03596010552952 | K022902 | 000 |
| 00885556020517 | K022902 | 000 |
| 00885556020777 | K022902 | 000 |
| 00885556021187 | K022902 | 000 |
| 00885556021743 | K022902 | 000 |
| 00885556021866 | K022902 | 000 |
| 00885556022177 | K022902 | 000 |
| 00885556022528 | K022902 | 000 |
| 00885556022771 | K022902 | 000 |
| 00885556020173 | K022902 | 000 |
| 03596010591814 | K022902 | 000 |
| 03596010591807 | K022902 | 000 |
| 03596010552969 | K022902 | 000 |
| 03596010552976 | K022902 | 000 |
| 03596010552983 | K022902 | 000 |
| 03596010591753 | K022902 | 000 |
| 03596010591760 | K022902 | 000 |
| 03596010591777 | K022902 | 000 |
| 03596010591784 | K022902 | 000 |
| 03596010591791 | K022902 | 000 |
| 00885556059210 | K022902 | 000 |