FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
K Number: K042515
·
Decision Mar 14, 2005
Classifications
1
FEI Numbers
320
Registration Numbers
320
Same Product Code
902
Applicant Total
423
Review Days
179
Basic Information
- Device Name
- SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
- K Number
- K042515
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SMITH & NEPHEW, INC.
- Date Received
- September 16, 2004
- Decision Date
- March 14, 2005
- Product Code
- JWH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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Other Clearances by SMITH & NEPHEW, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| K161233 | OXINIUM DH Fermoral Heads | Dec 14, 2016 | Substantially Equivalent |
| K161264 | TRIGEN Low Profile Bone Screws | Nov 23, 2016 | Substantially Equivalent |
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| K161665 | VLP Wrist Fracture System | Nov 15, 2016 | Substantially Equivalent |
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| K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors | Dec 2, 2015 | Substantially Equivalent |