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Data / Medical devices / United States / Aegis Meditec, Inc.

Aegis Meditec, Inc.: FDA-registered device maker in Costa Mesa, CA, United States, 4 510(k) clearances

Aegis Meditec, Inc. is registered with the FDA (registration 3009790163) in Costa Mesa, CA, United States. It lists 35 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 20, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Aegis Meditec, Inc.
FDA registration number
3009790163
Address
130 McCormick Ave Suite 106, Costa Mesa, CA, United States, 92626
Owner or operator
Aegis Spine (10031416)
Roles
Specification developer
First device listed
February 9, 2021
Registered through
2026
Brand names listed
ABTross ALIF Expandable Cage System, Awl, Bender, Bone Screw Starter, Broach, Burr, CALIPER, Compressor and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Specification developeraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Specification developeraccessdata.fda.gov
AwlHWJ1Specification developeraccessdata.fda.gov
BenderHXW1Specification developeraccessdata.fda.gov
Bit, DrillHTW1Specification developeraccessdata.fda.gov
BroachHTQ1Specification developeraccessdata.fda.gov
Burr, OrthopedicHTT1Specification developeraccessdata.fda.gov
CaliperKTZ1Specification developeraccessdata.fda.gov
CorkscrewHWI1Specification developeraccessdata.fda.gov
Cutter, WireHXZ1Specification developeraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Specification developeraccessdata.fda.gov
Driver, ProsthesisHWR1Specification developeraccessdata.fda.gov
ExtractorHWB1Specification developeraccessdata.fda.gov
FileHTP1Specification developeraccessdata.fda.gov
ForkHXE1Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Specification developeraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Specification developeraccessdata.fda.gov
ImpactorHWA1Specification developeraccessdata.fda.gov
Instrument, CompressionHWN1Specification developeraccessdata.fda.gov
Knife, OrthopedicHTS1Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Specification developeraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Specification developeraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Specification developeraccessdata.fda.gov
ProbeHXB1Specification developeraccessdata.fda.gov
ReamerHTO1Specification developeraccessdata.fda.gov
RongeurHTX1Specification developeraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Specification developeraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Specification developeraccessdata.fda.gov
ScrewdriverHXX1Specification developeraccessdata.fda.gov
Starter, Bone ScrewHWD1Specification developeraccessdata.fda.gov
Stripper, SurgicalHRT1Specification developeraccessdata.fda.gov
TampHXG1Specification developeraccessdata.fda.gov
Tap, BoneHWX1Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.fda.gov
WrenchHXC1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 20, 2023K223521ZESPIN SI Joint Fusion SystemOURSubstantially EquivalentAegis Spine, Inc.accessdata.fda.gov
January 11, 2023K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemKWQSubstantially EquivalentAegis Spine, Inc.accessdata.fda.gov
June 30, 2022K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate SystemOURSubstantially EquivalentAegis Spine, Inc.accessdata.fda.gov
February 16, 2021K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate SystemOURSubstantially EquivalentAegis Spineaccessdata.fda.gov

Compare with other makers

Updated January 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.