510(k) K081124
- Device
- MDF REVISION HIP SYSTEM
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K081124
- Product code
- MEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-07-31
- Date received
- 2008-04-21
- Regulation
- 888.3353
- Classification name
- Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
- 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
- RISHI SINHA
- Address
- 1450 Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers
- 1450662
- 3000236920
- 2242737
- 3005180920
- 2133928
- 3007913880
- 1000547811
- 3013176080
- 3002807315
- 3021008900
- 3010386387
- 3010057495
- 3006801265
- 1835831
- 3009871135
- 3012275107
- 8044172
- 1644408
- 3023852420
- 1834331
- 1226188
- 1018470
- 3010287737
- 3005323511
- 3006809628
- 3025603301
- 3009760038
- 3030338875
- 3005061536
- 3014170143
- 3010163695
- 3034676720
- 1643264
- 3006946279
- 3026771806
- 1043653
- 1219655
- 9610612
- 2246552
- 3014763043
- 3007740680
- 3002806535
- 1721676
- 3015516266
- 3009475821
- 3010041693
- 3012916784
- 3006395932
- 1218882
- 3004976965
- 3002807314
- 3004153896
- 3013302242
- 3007923096
- 3015259876
- 3013014058
- 3021386586
- 9613350
- 2249697
- 3012392319
- 3012523063
- 3010288357
- 3016438694
- 3009973336
- 3008110533
- 3010097171
- 9615800
- 3006128100
- 3002907620
- 3002808022
- 3004153240
- 3038503932
- 3010155661
- 1649518
- 9681465
- 3001278222
- 3015167917
- 3005562917
- 9681642
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556022733 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010620590 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010620606 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010620613 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010620620 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010620637 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010620644 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010620651 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010620668 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010619556 | NA | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556022382 | NA | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556022412 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556022573 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556022597 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556025949 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556023075 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556023099 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556023136 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556023280 | NA | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556023433 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556023464 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556023518 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556023778 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556023785 | NA | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556023891 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556023969 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556024478 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556024713 | REDAPT | Smith & Nephew, Inc. | 2015-08-30 |
Legacy Summary
summary
FDA Review
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