Atlas FDA

NuVasive AttraX Putty

FDA 510(k) clearance K191974 · decided 2019-11-03

Clearance details

K-number
K191974
Device name
NuVasive AttraX Putty
Applicant
Nu Vasive, Incorporated
Decision
Substantially Equivalent
Date received
2019-07-24
Decision date
2019-11-03
Days to decision
102 days
Clearance type
Traditional
Product code
MQV
Device class
2
Regulation number
888.3045
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.