Last synced on 12 July 2024 at 11:04 pm

Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K143159
510(k) Type
Traditional
Applicant
SpineGuard, S.A.
Country
France
FDA Decision
Substantially Equivalent
Decision Date
1/23/2015
Days to Decision
81 days
Submission Type
Summary

Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K143159
510(k) Type
Traditional
Applicant
SpineGuard, S.A.
Country
France
FDA Decision
Substantially Equivalent
Decision Date
1/23/2015
Days to Decision
81 days
Submission Type
Summary