The following data is part of a premarket notification filed by Medicrea International S.a. with the FDA for Pass Lp Spinal System.
| Device ID | K182240 |
| 510k Number | K182240 |
| Device Name: | PASS LP Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Medicrea International S.A. 5389 Route De Strasbourg Rillieux-la-pape, FR 69140 |
| Contact | David Ryan |
| Correspondent | David Ryan Medicrea International S.A. 5389 Route De Strasbourg Rillieux-la-pape, FR 69140 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-20 |
| Decision Date | 2018-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03613720282532 | K182240 | 000 |
| 03613720274650 | K182240 | 000 |
| 03613720274643 | K182240 | 000 |
| 03613720274636 | K182240 | 000 |
| 03613720273011 | K182240 | 000 |
| 03613720273004 | K182240 | 000 |
| 03613720272885 | K182240 | 000 |
| 03613720272878 | K182240 | 000 |
| 03613720272861 | K182240 | 000 |
| 03613720272854 | K182240 | 000 |
| 03613720272847 | K182240 | 000 |
| 03613720272823 | K182240 | 000 |
| 03613720272816 | K182240 | 000 |
| 03613720272809 | K182240 | 000 |
| 03613720274667 | K182240 | 000 |
| 03613720272830 | K182240 | 000 |
| 03613720286554 | K182240 | 000 |
| 03613720285250 | K182240 | 000 |
| 03613720285243 | K182240 | 000 |
| 03613720284192 | K182240 | 000 |
| 03613720284185 | K182240 | 000 |
| 03613720284178 | K182240 | 000 |
| 03613720284161 | K182240 | 000 |
| 03613720284154 | K182240 | 000 |
| 03613720284147 | K182240 | 000 |
| 03613720284130 | K182240 | 000 |
| 03613720284123 | K182240 | 000 |
| 03613720284116 | K182240 | 000 |
| 03613720284109 | K182240 | 000 |
| 03613720286561 | K182240 | 000 |
| 03613720272793 | K182240 | 000 |