The following data is part of a premarket notification filed by Influence, Inc. with the FDA for Stapletac Bone Anchor System.
Device ID | K992277 |
510k Number | K992277 |
Device Name: | STAPLETAC BONE ANCHOR SYSTEM |
Classification | Screw, Fixation, Bone |
Applicant | INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-07 |
Decision Date | 1999-07-30 |
Summary: | summary |