The following data is part of a premarket notification filed by Neos Surgery S.l. with the FDA for Cranial Loop, Cranial Loop L And Cranial Loop Xl And Cranial Bone Fixation System.
| Device ID | K132044 |
| 510k Number | K132044 |
| Device Name: | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM |
| Classification | Cover, Burr Hole |
| Applicant | NEOS SURGERY S.L. 901 KING STREET SUITE 101 Alexandria, VA 22314 |
| Contact | Cherita James |
| Correspondent | Cherita James NEOS SURGERY S.L. 901 KING STREET SUITE 101 Alexandria, VA 22314 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-02 |
| Decision Date | 2013-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 48437006085067 | K132044 | 000 |
| 18437006085059 | K132044 | 000 |
| 48437006085043 | K132044 | 000 |