510(k) K073175
- Device
- JOURNEY UNICONDYLAR FEMORAL IMPLANT
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K073175
- Product code
- HSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-12-20
- Date received
- 2007-11-13
- Regulation
- 888.3520
- Classification name
- Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- MARLON RIDLEY
- Address
- 1450 Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers
- 1423662
- 1450662
- 1000200989
- 2242737
- 3005180920
- 2133928
- 3009241418
- 3013176080
- 3017410889
- 3021008900
- 3006801265
- 3001239363
- 1421101
- 2183744
- 1644408
- 1834331
- 3003541440
- 1018470
- 3020703621
- 3000264985
- 3013194153
- 3007963827
- 1833920
- 1827096
- 3002579136
- 3015806723
- 3025603301
- 3005061536
- 2031093
- 3010163695
- 3004142400
- 1643264
- 1223434
- 3016090213
- 2028632
- 3004358587
- 1043653
- 1219655
- 2246552
- 3014763043
- 1721676
- 3011061242
- 2532027
- 3010041693
- 3006395932
- 3004976965
- 3013302242
- 3013014058
- 3010039400
- 2249697
- 3010331645
- 3012523063
- 3016438694
- 3009973336
- 3008110533
- 3010097171
- 3015231789
- 3002907620
- 3015398319
- 3002808022
- 3004153240
- 3038503932
- 9681465
- 3010400367
- 3011015572
- 3030412764
- 1057425
- 1645151
- 1000550978
- 3010047402
- 3007311878
- 3011534620
- 3009882462
- 3009732568
- 3020155054
- 1526534
- 3002807295
- 1828288
- 1828464
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03596010627414 | JOURNEY OXINIUM | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627308 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627315 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627339 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627346 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627360 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627377 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627384 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627391 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627407 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627421 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627438 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010629777 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627322 | JOURNEY OXINIUM | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627575 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627445 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627452 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627469 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627476 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627483 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627490 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627506 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627513 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627520 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627537 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627544 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627551 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010627568 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
Legacy Summary
summary
FDA Review
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