510(k) K962557
- Device
- GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
- Applicant
- SMITH & NEPHEW RICHARDS, INC.
- 510(k) number
- K962557
- Product code
- JWH
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1996-12-05
- Date received
- 1996-07-01
- 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
- Traditional
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- THOMAS L CRAIG
- Address
- 1450 E. Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers
- 1450662
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03596010488527 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010453020 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010452986 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469311 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469243 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469205 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469199 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010488596 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010488589 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010488572 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010488565 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010488558 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010488541 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010488534 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010452979 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010488510 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010488503 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469328 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469304 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469298 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469281 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469274 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469267 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469236 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469229 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469212 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010469182 | GENESIS II | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010452993 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010453082 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010453075 | PROFIX | Smith & Nephew, Inc. | 2015-08-30 |
Legacy Summary
summary