The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Tangors Multifunctional Posterior System.
| Device ID | K120891 |
| 510k Number | K120891 |
| Device Name: | TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ULRICH GMBH & CO. KG 612 TRADE CENTER BLVD Chesterfield, MO 63005 |
| Contact | Hans Stover |
| Correspondent | Hans Stover ULRICH GMBH & CO. KG 612 TRADE CENTER BLVD Chesterfield, MO 63005 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-23 |
| Decision Date | 2012-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04052536014293 | K120891 | 000 |
| 04052536005529 | K120891 | 000 |
| 04052536005543 | K120891 | 000 |
| 04052536005550 | K120891 | 000 |
| 04052536005741 | K120891 | 000 |
| 04052536005758 | K120891 | 000 |
| 04052536005765 | K120891 | 000 |
| 04052536006021 | K120891 | 000 |
| 04052536006038 | K120891 | 000 |
| 04052536006045 | K120891 | 000 |
| 04052536006052 | K120891 | 000 |
| 04052536006069 | K120891 | 000 |
| 04052536012916 | K120891 | 000 |
| 04052536014125 | K120891 | 000 |
| 04052536014279 | K120891 | 000 |
| 04052536014286 | K120891 | 000 |
| 04052536005512 | K120891 | 000 |