510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Orthosoft Inc (D/B/A Zimmer Cas)

Montreal, CA

Orthosoft Inc (D/B/A Zimmer Cas) appears in FDA device records in Montreal, CA. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
20
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 20 510(k) clearances for Orthosoft Inc (D/B/A Zimmer Cas) between 2017 and 2026. The busiest year on record is 2019, with 5. The most recent is 2026, with 3.

Clearances by year, as a table
510(k) clearance decisions for Orthosoft Inc (D/B/A Zimmer Cas), by decision year
YearClearances
20171
20195
20201
20211
20222
20234
20242
20251
20263
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261510Signature™ ONE SystemQHESubstantially Equivalent
K260582ROSA® Shoulder SystemOLOSubstantially Equivalent
K260104Signature™ ONE SystemQHESubstantially Equivalent
K251314Rosa® Knee SystemOLOSubstantially Equivalent
K242864ROSA® Knee SystemOLOSubstantially Equivalent
K233199ROSA® Shoulder SystemOLOSubstantially Equivalent
K232425Signature™ ONE SystemQHESubstantially Equivalent
K230567OptiVu™ ROSA® MxRSBFSubstantially Equivalent
K231162ROSA Hip SystemLLZSubstantially Equivalent
K230180Rosa Knee SystemOLOSubstantially Equivalent
K220733OptiVu ROSA MxRSBFSubstantially Equivalent
K213708ROSA® Knee SystemOLOSubstantially Equivalent
K212560Signature™ ONE SystemQHESubstantially Equivalent
K200615Signature ONE SystemQHESubstantially Equivalent
K192080iASSIST Knee SystemOLOSubstantially Equivalent
K192074Signature ONE SystemQHESubstantially Equivalent
K183544Efficient Care 3D PlanningLLZSubstantially Equivalent
K190595Signature ONE SystemKWTSubstantially Equivalent
K182964ROSA Knee SystemOLOSubstantially Equivalent
K171269X-PSI Knee SystemJWHSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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