510(k) K112941
- Device
- LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K112941
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-12-20
- Date received
- 2011-10-04
- Regulation
- 888.3560
- Classification name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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
- DAVID HENLEY
- Address
- 7135 Goodlett Farms Pkwy. Cordova TN US 38016 38016
FDA Registration Numbers
- 1450662
- 3008985661
- 3033796901
- 3014252644
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556234051 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556233450 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556233504 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556233559 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556233603 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556233702 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556233757 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556233801 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556233856 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556233900 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556233955 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234006 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234655 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234105 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234150 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234204 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234259 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234303 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234358 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234402 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234457 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234501 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234556 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
| 00885556234600 | LEGION | Smith & Nephew, Inc. | 2015-08-30 |
Legacy Summary
summary