The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Anchorlok And Anchorlok Rl Soft Tissue Anchor System.
Device ID | K971282 |
510k Number | K971282 |
Device Name: | ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Christie Manuel |
Correspondent | Christie Manuel WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-07 |
Decision Date | 1997-06-27 |
Summary: | summary |