The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Natural Bridge Lp Transverse Connectors.
Device ID | K072914 |
510k Number | K072914 |
Device Name: | NATURAL BRIDGE LP TRANSVERSE CONNECTORS |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
Contact | Richard W Woods |
Correspondent | Richard W Woods K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-12 |
Decision Date | 2008-01-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10888857142602 | K072914 | 000 |
10888857141445 | K072914 | 000 |
10888857141483 | K072914 | 000 |
10888857141544 | K072914 | 000 |
10888857141582 | K072914 | 000 |
10888857141629 | K072914 | 000 |
10888857141643 | K072914 | 000 |
10888857141742 | K072914 | 000 |
10888857141889 | K072914 | 000 |
10888857141940 | K072914 | 000 |
10888857141407 | K072914 | 000 |