The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Modification To Synergy Spinal System.
Device ID | K010515 |
510k Number | K010515 |
Device Name: | MODIFICATION TO SYNERGY SPINAL SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
Contact | Lynn M Rodarti |
Correspondent | Lynn M Rodarti INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
Product Code | KWP |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-02-22 |
Decision Date | 2001-03-22 |