The following data is part of a premarket notification filed by Spineguard, S.a. with the FDA for 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.
| Device ID | K143159 |
| 510k Number | K143159 |
| Device Name: | 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 |
| Classification | Neurosurgical Nerve Locator |
| Applicant | SpineGuard, S.A. 5-7 Rue De L’Amiral Courbet Saint Mande, FR 94160 |
| Contact | Stephane Bette |
| Correspondent | Donald W. Guthner Orgenix LLC 111 Hill Road Douglassville, PA 19518 |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2015-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03662674000129 | K143159 | 000 |
| 03662674000013 | K143159 | 000 |
| 03662674000020 | K143159 | 000 |
| 03662674000037 | K143159 | 000 |
| 03662674000044 | K143159 | 000 |
| 03662674000051 | K143159 | 000 |
| 03662674000068 | K143159 | 000 |
| 03662674000075 | K143159 | 000 |
| 03662674000112 | K143159 | 000 |
| 03662674000006 | K143159 | 000 |