Skip to content
Scan

Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K190035

Biomet Headless Compression and Twist-Off Screws · Biomet, Inc. · decided 2019-02-07 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Cannulated Drill Bit AO110027745Biomet Orthopedics, LLCHWC00887868469954
HEAD RELIEF DRILL BIT AO110018534Biomet Orthopedics, LLCHWC00887868137877
CANNULATED DRILL BIT AO110027745Biomet Orthopedics, LLCHWC00887868137860
T7 CANNULATED DRIVER AO110038661Biomet Orthopedics, LLCHWC00887868254079
Cannulated Drill Bit AO110018532Biomet Orthopedics, LLCHWC00887868467219
T7 DRIVER SOLID AO110018541Biomet Orthopedics, LLCHWC00887868138539
CANNULATED DRILL BIT AO110018532Biomet Orthopedics, LLCHWC00887868137891
T7 CANNULATED DRIVER AO110018531Biomet Orthopedics, LLCHWC00887868138553
K-WIRE110025493Biomet Orthopedics, LLCHWC00887868137914
Head Relief Drill Bit AO110018533Biomet Orthopedics, LLCHWC00887868467226
K-Wire Depth Gauge110018535Biomet Orthopedics, LLCHWC00887868467240
K-WIRE110018527Biomet Orthopedics, LLCHWC00887868137907
Head Relief Drill Bit AO110018534Biomet Orthopedics, LLCHWC00887868467233
K-Wire110018527Biomet Orthopedics, LLCHWC00887868467202
TWIST-OFFFINISHING DRIVER AO110018537Biomet Orthopedics, LLCHWC00887868134067
HEAD RELIEF DRILL BIT AO110018533Biomet Orthopedics, LLCHWC00887868137884
K-WIRE110018526Biomet Orthopedics, LLCHWC00887868138515
0.9MM K-WIRE DEPTH GAUGE110018535Biomet Orthopedics, LLCHWC00887868134050
K-Wire110025493Biomet Orthopedics, LLCHWC00887868469565
T7 SOLID DRIVER AO110038662Biomet Orthopedics, LLCHWC00887868254086
Ratchet Handle110017406Biomet Orthopedics, LLCHWC00887868466540