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Data / Medical devices / United States / Clariance, Inc.

Clariance, Inc.: FDA-registered device maker in Farmers Branch, TX, United States, 22 510(k) clearances

Clariance, Inc. is registered with the FDA (registration 3009962553) in Farmers Branch, TX, United States. It lists 22 device types. The FDA files 22 510(k) clearances under its listings, the newest dated January 14, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Clariance, Inc.
FDA registration number
3009962553
Address
3321 Towerwood Dr Ste 130, Farmers Branch, TX, United States, 75234
Owner or operator
CLARIANCE-SAS (10043711)
Roles
Complaint file establishment, Manufacturer for export, Repackager or relabeler
First device listed
March 13, 2013
Registered through
2026
Brand names listed
Aggeris-C, Bone Awl, ERISMA LP MIS, ERISMA® LP_NAVIGATED INSTRUMENTS, Elegance® Anterior Cervical Plate, Erisma-LP, Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System, Erisma® LP MIS and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
AwlHWJ1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
CuretteHTF1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Driver, ProsthesisHWR1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
ElevatorHTE1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Gauge, DepthHTJ1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Instrument, Cranioplasty Material FormingHBX1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
ProbeHXB1Manufacturer for exportaccessdata.fda.gov
RaspHTR1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Repackager or relabeleraccessdata.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 14, 2025K243904Elegance® Anterior Cervical plateKWQSubstantially EquivalentClarianceaccessdata.fda.gov
December 31, 2024K243670Idys® LIFMAXSubstantially EquivalentClarianceaccessdata.fda.gov
July 24, 2024K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISNKBSubstantially EquivalentClarianceaccessdata.fda.gov
April 26, 2024K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemNKBSubstantially EquivalentClarianceaccessdata.fda.gov
March 22, 2024K240715Idys® C ZP 3DTiOVESubstantially EquivalentClarianceaccessdata.fda.gov
March 30, 2022K220182Aggeris™-CKWQSubstantially EquivalentClarianceaccessdata.fda.gov
October 12, 2021K212562Idys-C ZP 3DTiOVESubstantially EquivalentClariance, SAaccessdata.fda.gov
April 12, 2021K200919Idys ALIF 3DTiMAXSubstantially EquivalentClarianceaccessdata.fda.gov
April 1, 2021K202032Idys LLIF 3DTiOVDSubstantially EquivalentClariance, Sasaccessdata.fda.gov
February 26, 2021K202956Erisma LP Navigated InstrumentsOLOSubstantially EquivalentClariance, Sasaccessdata.fda.gov
May 29, 2020K200920Idys ALIF ZP 3DTiMAXSubstantially EquivalentClariance, Sasaccessdata.fda.gov
November 4, 2019K192168Idys ALIF ZP 3DTiOVDSubstantially EquivalentClariance, Sasaccessdata.fda.gov
June 6, 2019K191263Idys ALIF TiVacOVDSubstantially EquivalentClariance, Sasaccessdata.fda.gov
March 1, 2019K183259Idys™ TLIF TiVacMAXSubstantially EquivalentClariance, Sasaccessdata.fda.gov
December 15, 2017K172465Idys™ TLIF 3DTi CagesMAXSubstantially EquivalentClariance, Sasaccessdata.fda.gov
November 8, 2017K172083Idys™ ALIF SystemOVDSubstantially EquivalentClariance, Sasaccessdata.fda.gov
February 14, 2017K170163Erisma® LP Spinal Fixation SystemNKBSubstantially EquivalentClariance, Sasaccessdata.fda.gov
October 27, 2016K162367Erisma® LP MISNKBSubstantially EquivalentClariance, Sasaccessdata.fda.gov
March 8, 2016K153326Erisma-LP Spinal Fixation SystemNKBSubstantially EquivalentClariance, Sasaccessdata.fda.gov
November 13, 2013K130853IDYS(TM) CODPSubstantially EquivalentClarianceaccessdata.fda.gov
October 10, 2013K131178IDYS LIF CAGESMAXSubstantially EquivalentClarianceaccessdata.fda.gov
August 13, 2012K120469ERISMA-LPNKBSubstantially EquivalentClarianceaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
July 1, 201983218Class IIITerminatedErisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4Potential for the polyaxial screw to become disassembled during implant.accessdata.fda.gov

Compare with other makers

Updated January 14, 2025. 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.