Medical Device Manufacturer · US , Glendale , CA

Osteomed Corp.

27 submissions · 26 cleared · Since 1991
27
Total
26
Cleared
0
Denied

Osteomed Corp. — FDA 510(k) Submissions

Osteomed Corp. has submitted 27 FDA 510(k) premarket notifications since 1991, of which 26 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Screw, Fixation, Bone, Screw, Fixation, Intraosseous, Plate, Bone, Prosthesis, Toe, Constrained, Polymer, External Mandibular Fixator And/or Distractor . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
OsteoMed Cannulated Screw System
K151021 · HWC Screw, Fixation, Bone · Orthopedic
Jul 2015 90d
OSTEOMED CRANIAL FLAP FIXATION SYSTEM
K022277 · GXN Plate, Cranioplasty,... · Neurology
Apr 2003 260d
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022887 · KWH Prosthesis, Toe,... · Orthopedic
Nov 2002 88d
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022886 · KWH Prosthesis, Toe,... · Orthopedic
Nov 2002 87d
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
K023260 · HWC Screw, Fixation, Bone · Orthopedic
Oct 2002 18d
INTRAORAL MANDIBULAR DISTRACTION SYSTEM
K013618 · MQN External Mandibular... · Dental
Aug 2002 282d
OSA RIGID INTERNAL FIXATION SYSTEM
K021618 · JEY Plate, Bone · Dental
Aug 2002 84d
OSTEOMED BIORESORBABLE FIXATION SYSTEM
K012486 · DZL Screw, Fixation,... · Dental
Jan 2002 167d
AUTO-DRIVE LAG SCREW SYSTEM
K010964 · HWC Screw, Fixation, Bone · Orthopedic
Jul 2001 97d
2.0/2.4 CANNULATED SCREW SYSTEM
K010783 · HWC Screw, Fixation, Bone · Orthopedic
May 2001 76d
OSTEOMED INTRAORAL DISTRACTION SYSTEM
K990944 · MQN External Mandibular... · Dental
Jun 1999 86d
AUTO-DRIVE BONE SCREW
K974785 · HWC Screw, Fixation, Bone · Orthopedic
Mar 1998 86d
OSTEOMED QUICKFIX
K962774 · DZL Screw, Fixation,... · Dental
Oct 1997 451d
OSTEOPOWER SYSTEM AND ACCESSORIES
K971692 · KMW Handpiece, Rotary Bone... · Dental
Jun 1997 51d
OSTEOMED TRAM
K963394 · JEY Plate, Bone · Dental
Nov 1996 78d
OSTEOMED MSS
K961418 · DZL Screw, Fixation,... · Dental
Oct 1996 196d
SUPER SCREW 3.5 MM
K954330 · HWC Screw, Fixation, Bone · Orthopedic
Dec 1995 84d
ORTHOPEDIC SCREW FIXATION
K932350 · HWC Screw, Fixation, Bone · Orthopedic
Jul 1995 782d
ORTHOPEDIC BONE PLATE
K932352 · HRS Plate, Fixation, Bone · Orthopedic
Jul 1995 782d
THE OSTEOMED B POWER SYSTEM AND ACCESSORIES
K933101 · KIJ Instrument, Surgical,... · Orthopedic
Nov 1994 501d
ORTHOPEDIC SMOOTH PIN FIXATION
K932348 · HTY Pin, Fixation, Smooth · Orthopedic
Mar 1994 291d
ORTHOPEDIC THREADED PIN FIXATION
K932349 · JDW Pin, Fixation, Threaded · Orthopedic
Mar 1994 291d
OSTEOMED GREAT TOE SYSTEM
K922211 · LZJ Prosthesis, Toe... · Orthopedic
Nov 1993 546d
M3 LAG SCREW FIXATION SYSTEM
K924018 · HWC Screw, Fixation, Bone · Orthopedic
Apr 1993 233d
OSTEOMED M3 SYSTEM (SBF SYSTEM)
K924138 · JEY Plate, Bone · Dental
Feb 1993 183d
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