The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Mbaresorb Implant.
| Device ID | K051611 |
| 510k Number | K051611 |
| Device Name: | MBARESORB IMPLANT |
| Classification | Screw, Fixation, Bone |
| Applicant | KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad, CA 92011 |
| Contact | John G Spampinato |
| Correspondent | John G Spampinato KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad, CA 92011 |
| Product Code | HWC |
| Subsequent Product Code | MBJ |
| Subsequent Product Code | MJW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-17 |
| Decision Date | 2005-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2480400120 | K051611 | 000 |
| M2480400110 | K051611 | 000 |
| M2480400100 | K051611 | 000 |
| M2480400090 | K051611 | 000 |
| M2480400080 | K051611 | 000 |
| M248MBASET1 | K051611 | 000 |