Atlas FDA

Arthrex BioSync® Bone Wedge

FDA 510(k) clearance K151256 · decided 2015-08-12

Clearance details

K-number
K151256
Device name
Arthrex BioSync® Bone Wedge
Applicant
Arthex, Inc.
Decision
Substantially Equivalent
Date received
2015-05-12
Decision date
2015-08-12
Days to decision
92 days
Clearance type
Traditional
Product code
PLF
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Naples, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.