The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew, Inc. Patient Matched Technology.
| Device ID | K082358 |
| 510k Number | K082358 |
| Device Name: | SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Megan Bevill |
| Correspondent | Megan Bevill SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-18 |
| Decision Date | 2008-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556583111 | K082358 | 000 |
| 00885556492697 | K082358 | 000 |
| 00885556492680 | K082358 | 000 |
| 00885556492673 | K082358 | 000 |
| 00885556077191 | K082358 | 000 |
| 00885556077146 | K082358 | 000 |
| 00885556076958 | K082358 | 000 |
| 00885556076712 | K082358 | 000 |
| 00885556076361 | K082358 | 000 |
| 00885556076354 | K082358 | 000 |
| 03596010653161 | K082358 | 000 |
| 03596010653154 | K082358 | 000 |
| 03596010653147 | K082358 | 000 |
| 03596010653130 | K082358 | 000 |
| 03596010653123 | K082358 | 000 |
| 00885556492703 | K082358 | 000 |
| 00885556533420 | K082358 | 000 |
| 00885556583104 | K082358 | 000 |
| 00885556583098 | K082358 | 000 |
| 00885556583081 | K082358 | 000 |
| 00885556583074 | K082358 | 000 |
| 00885556583067 | K082358 | 000 |
| 00885556583050 | K082358 | 000 |
| 00885556583043 | K082358 | 000 |
| 00885556583036 | K082358 | 000 |
| 00885556583029 | K082358 | 000 |
| 00885556583012 | K082358 | 000 |
| 00885556583005 | K082358 | 000 |
| 00885556533475 | K082358 | 000 |
| 00885556533468 | K082358 | 000 |
| 00885556533451 | K082358 | 000 |
| 03596010653116 | K082358 | 000 |