The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Mobis Ii St Spinal Implant.
| Device ID | K141405 |
| 510k Number | K141405 |
| Device Name: | MOBIS II ST SPINAL IMPLANT |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SIGNUS MEDIZINTECHNIK GMBH 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb SIGNUS MEDIZINTECHNIK GMBH 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-28 |
| Decision Date | 2014-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04047844016176 | K141405 | 000 |
| 04047844016046 | K141405 | 000 |
| 04047844016039 | K141405 | 000 |
| 04047844016022 | K141405 | 000 |
| 04047844016015 | K141405 | 000 |
| 04047844016008 | K141405 | 000 |
| 04047844015995 | K141405 | 000 |
| 04047844015988 | K141405 | 000 |
| 04047844015971 | K141405 | 000 |
| 04047844015964 | K141405 | 000 |
| 04047844015940 | K141405 | 000 |
| 04047844015933 | K141405 | 000 |
| 04047844015957 | K141405 | 000 |
| 04047844016053 | K141405 | 000 |
| 04047844016169 | K141405 | 000 |
| 04047844016152 | K141405 | 000 |
| 04047844016145 | K141405 | 000 |
| 04047844016138 | K141405 | 000 |
| 04047844016121 | K141405 | 000 |
| 04047844016114 | K141405 | 000 |
| 04047844016107 | K141405 | 000 |
| 04047844016091 | K141405 | 000 |
| 04047844016084 | K141405 | 000 |
| 04047844016077 | K141405 | 000 |
| 04047844016060 | K141405 | 000 |
| 04047844015926 | K141405 | 000 |