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Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231708
510(k) Type
Traditional
Applicant
AxoGen Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/12/2023
Days to Decision
122 days
Submission Type
Summary

Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231708
510(k) Type
Traditional
Applicant
AxoGen Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/12/2023
Days to Decision
122 days
Submission Type
Summary