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

Irvine, CA, US

Ellipse Technologies, Inc. appears in FDA device records in Irvine, CA. FDA records list 13 510(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
13
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 13 510(k) clearances for Ellipse Technologies, Inc. between 2011 and 2016. The busiest year on record is 2014, with 6. The most recent is 2016, with 1.

Clearances by year, as a table
510(k) clearance decisions for Ellipse Technologies, Inc., by decision year
YearClearances
20111
20122
20132
20146
20151
20161
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K160325PRECICE Intramedullary Limb Lengthening SystemHSBSubstantially Equivalent
K141278MAGEC SPINAL BRACING AND DISTRACTION SYSTEMPGNSubstantially Equivalent
K141739RESIDUAL LIMB LENGTHENING SYSTEMHSBSubstantially Equivalent
K140613MAGEC SPINAL BRACING AND DISTRACTION SYSTEMPGNSubstantially Equivalent
K141447PRECICE TRAUMA NAIL SYSTEMHSBSubstantially Equivalent
K141023PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMHSBSubstantially Equivalent
K140178ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEMPGNSubstantially Equivalent
K131490ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMHSBSubstantially Equivalent
K133289PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMHSBSubstantially Equivalent
K131677PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMHSBSubstantially Equivalent
K113219ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMHSBSubstantially Equivalent
K113695ELLIPSE PRECICE TRAUMA NAIL SYSTEMHSBSubstantially Equivalent
K101997ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEMHSBSubstantially 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

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