TRIGEN Low Profile Bone Screws
FDA 510(k) clearance K161264 · decided 2016-11-23
Clearance details
- K-number
- K161264
- Device name
- TRIGEN Low Profile Bone Screws
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-05-05
- Decision date
- 2016-11-23
- Days to decision
- 202 days
- Clearance type
- Special
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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