| Proprietary Name: |
BIOSURE DRIVER 5MM; BIOSURE REGEN SCREW 5 X 20MM; BIOSURE REGENESORB; SCREW BIOSURE REGENESORB 10MM X 20MM; SCREW BIOSURE REGENESORB 10MM X 25MM; SCREW BIOSURE REGENESORB 10MM X 30MM; SCREW BIOSURE REGENESORB 10MM X 35MM; SCREW BIOSURE REGENESORB 11MM X 25MM; SCREW BIOSURE REGENESORB 11MM X 30MM; SCREW BIOSURE REGENESORB 11MM X 35MM; SCREW BIOSURE REGENESORB 12MM X 35MM; SCREW BIOSURE REGENESORB 5MM X 25MM; SCREW BIOSURE REGENESORB 6MM X 20MM; SCREW BIOSURE REGENESORB 6MM X 25MM; SCREW BIOSURE REGENESORB 6MM X 25MM RT; SCREW BIOSURE REGENESORB 7MM X 20MM; SCREW BIOSURE REGENESORB 7MM X 25MM; SCREW BIOSURE REGENESORB 7MM X 25MM RT; SCREW BIOSURE REGENESORB 7MM X 30MM; SCREW BIOSURE REGENESORB 8MM X 20MM; SCREW BIOSURE REGENESORB 8MM X 25MM; SCREW BIOSURE REGENESORB 8MM X 25MM RT; SCREW BIOSURE REGENESORB 8MM X 30MM; SCREW BIOSURE REGENESORB 8MM X 35MM; SCREW BIOSURE REGENESORB 9MM X 20MM; SCREW BIOSURE REGENESORB 9MM X 25MM; SCREW BIOSURE REGENESORB 9MM X 30MM; SCREW BIOSURE REGENESORB 9MM X 35MM |
| Classification Name: |
FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
| Product Code: |
MAI |
| Device Class: |
2 |
| Regulation Number: |
888.3030 |
| Medical Specialty: |
Orthopedic |
| Registered Establishment Name: |
SMITH & NEPHEW INC.
|
| Registered Establishment Number: |
3003604053
|
| Premarket Submission Number: |
K142948 |
| Owner/Operator: |
Smith & Nephew, Inc. |
| Owner/Operator Number: |
1020279
|
| Establishment Operations: |
Specification Developer
|
