The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Ligament Anchor.
Device ID | K926270 |
510k Number | K926270 |
Device Name: | MITEK LIGAMENT ANCHOR |
Classification | Staple, Fixation, Bone |
Applicant | MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
Contact | Edward F Kent |
Correspondent | Edward F Kent MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
Product Code | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-18 |
Decision Date | 1993-10-22 |