510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Clariance, Inc.

Dallas, TX, US

Clariance, Inc. appears in FDA device records in Dallas, TX. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 11 510(k) clearances for Clariance, Inc. between 2012 and 2025. The busiest year on record is 2024, with 4. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Clariance, Inc., by decision year
YearClearances
20121
20132
20212
20221
20244
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243904Elegance® Anterior Cervical plateKWQSubstantially Equivalent
K243670Idys® LIFMAXSubstantially Equivalent
K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISNKBSubstantially Equivalent
K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemNKBSubstantially Equivalent
K240715Idys® C ZP 3DTiOVESubstantially Equivalent
K220182Aggeris™-CKWQSubstantially Equivalent
K212562Idys-C ZP 3DTiOVESubstantially Equivalent
K200919Idys ALIF 3DTiMAXSubstantially Equivalent
K130853IDYS(TM) CODPSubstantially Equivalent
K131178IDYS LIF CAGESMAXSubstantially Equivalent
K120469ERISMA-LPNKBSubstantially Equivalent

Registered establishments

FDA registered establishments for Clariance, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30099625533009962553Clariance, Inc.3321 Towerwood Dr Ste 130, Farmers Branch, TX 75234 US2026and 12 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1986-2019Erisma- 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; 4. Erisma-LPT20 Snap Fit Tightening WrenchPotential for the polyaxial screw to become disassembled during implant.Class IIITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain