TITAN 3-D™ Wedge System
FDA 510(k) clearance K162241 · decided 2017-04-03
Clearance details
- K-number
- K162241
- Device name
- TITAN 3-D™ Wedge System
- Applicant
- Paragon 28
- Decision
- Substantially Equivalent
- Date received
- 2016-08-10
- Decision date
- 2017-04-03
- Days to decision
- 236 days
- Clearance type
- Traditional
- Product code
- PLF
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size recall (Z-0662-2020) | Paragon 28, Inc. | 2019-12-10 |