Portex® Lancet Point Spinal Needles With NRFit™ Connectors, Portex® Pencil Point Spinal Needles With NRFit™ Connectors
Needle, Spinal, Short Term
Smiths Medical ASD, Inc.
The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex® Lancet Point Spinal Needles With Nrfit™ Connectors, Portex® Pencil Point Spinal Needles With Nrfit™ Connectors.
Pre-market Notification Details
| Device ID | K172800 |
| 510k Number | K172800 |
| Device Name: | Portex® Lancet Point Spinal Needles With NRFit™ Connectors, Portex® Pencil Point Spinal Needles With NRFit™ Connectors |
| Classification | Needle, Spinal, Short Term |
| Applicant | Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Contact | Michael R. Johnson |
| Correspondent | Sunita Teekasingh Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Product Code | MIA |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2018-06-14 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55019517086780 | K172800 | 000 |
| 55019517070697 | K172800 | 000 |
| 35019517070686 | K172800 | 000 |
| 35019517070679 | K172800 | 000 |
| 55019517070666 | K172800 | 000 |
| 35019517070655 | K172800 | 000 |
| 35019517070648 | K172800 | 000 |
| 95019517070633 | K172800 | 000 |
| 35019517070600 | K172800 | 000 |
| 35019517070570 | K172800 | 000 |
| 35019517063534 | K172800 | 000 |
| 35019517063527 | K172800 | 000 |
| 55019517070734 | K172800 | 000 |
| 35019517071430 | K172800 | 000 |
| 35019517086755 | K172800 | 000 |
| 55019517075036 | K172800 | 000 |
| 55019517074978 | K172800 | 000 |
| 35019517074943 | K172800 | 000 |
| 35019517074110 | K172800 | 000 |
| 75019517074101 | K172800 | 000 |
| 35019517074097 | K172800 | 000 |
| 35019517074011 | K172800 | 000 |
| 75019517073852 | K172800 | 000 |
| 35019517071454 | K172800 | 000 |
| 35019517071447 | K172800 | 000 |
| 55019517063477 | K172800 | 000 |
Trademark Results [Portex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PORTEX 88465408 not registered Live/Pending |
XINGUARD INC. 2019-06-09 |
 PORTEX 79021653 3253922 Live/Registered |
DESA Tech AG 2006-02-23 |
 PORTEX 78236135 2886382 Live/Registered |
SMITHS MEDICAL ASD, INC. 2003-04-10 |
 PORTEX 77760408 3780380 Live/Registered |
Smiths Medical ASD, Inc. 2009-06-16 |
 PORTEX 75472252 2417963 Dead/Cancelled |
SMITHS MEDICAL ASD, INC. 1998-04-22 |
 PORTEX 73833948 1599410 Dead/Cancelled |
PIPER CAPITAL MANAGEMENT INCORPORATED 1989-10-26 |
 PORTEX 73475153 1342083 Dead/Cancelled |
Nilsson; Goran Alfred 1984-04-11 |
 PORTEX 71516916 0444703 Live/Registered |
PORTLAND PLASTICS LIMITED 1947-02-04 |
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