FDA device listing
BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 10 X 20 MM,BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 10 X 35 MM,BIOSURE PK…
FDA device listing 1185581456 · Smith & Nephew, Inc.
Key facts
| Proprietary names | BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 10 X 20 MM,BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 10 X 35 MM,BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 11 X 30 MM,BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 11 X 35 MM,BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 12 X 35 MM,BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 6 X 25 MM, REVERSE THREAD,BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 7 X 20 MM,BIOSURE PK PEEK… |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Premarket submissions | K083635 |
| Product codes | MBI |
| Device names | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3040 |
| Review panels | Orthopedic |
| Registered establishments | SMITH & NEPHEW INC. |
| Establishment registrations | 1219602, 3003604053 |
| FEI numbers | 1219602, 3003604053 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database