Device |
mesh, surgical, absorbable, orthopaedics, reinforcement of tendon |
Regulation Description |
Surgical mesh. |
Definition |
For reinforcement of soft tissue where weakness exists during tendon repair procedures. |
Physical State |
An absorbable mesh; either square, rectangular, round or of other various shapes |
Technical Method |
An absorbable mesh that reinforces soft tissue |
Target Area |
Tendon |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
Orthopedic |
Product Code | OWW |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
Submission Type |
510(k)
|
Regulation Number |
878.3300
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|