510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K163672Substantially Equivalent

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor

Nanova Biomaterials Inc, Columbia MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163672 is the FDA 510(k) clearance record for Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor, a class II device, cleared for Nanova Biomaterials, Inc. on under FDA product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue). FDA records list 8 510(k) clearances for Nanova Biomaterials, Inc., from to . As of , FDA records show no recalls naming K163672.

Clearance record

Decision date
Received
(129 days to decision)
Product code
MAI Fastener, Fixation, Biodegradable, Soft Tissue
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Nanova Biomaterials, Inc. 3806 Mojave Ct., Columbia MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAI

Trailing 12 months
5 clearances under product code MAI in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MAI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260