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

Irvine, CA, US

Interpore Cross Intl. appears in FDA device records in Irvine, CA. FDA records list 39 510(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
39
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 39 510(k) clearances for Interpore Cross Intl. between 1998 and 2005. The busiest year on record is 2001, with 8. The most recent is 2005, with 2.

Clearances by year, as a table
510(k) clearance decisions for Interpore Cross Intl., by decision year
YearClearances
19981
19996
20004
20018
20026
20034
20048
20052
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K050861PEEK CASMQPSubstantially Equivalent
K031399INTERGRO DBMMQVSubstantially Equivalent
K041407TITANIUM MESH IMPLANTMQPSubstantially Equivalent
K043229MODIFICATION TO ALTIUS OCT SYSTEMKWPSubstantially Equivalent
K042798C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K040928EXPANDABLE PEEK VBR IMPLANTMQPSubstantially Equivalent
K041794C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K041449SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEATKWPSubstantially Equivalent
K033961ALTIUS OCT SYSTEMKWPSubstantially Equivalent
K040168MODIFICATION TO GEO STRUCTUREMQPSubstantially Equivalent
K031772TI FENESTRATED PLATEKWPSubstantially Equivalent
K032095INTERPORE CROSS CEMENT RESTRICTORJDKSubstantially Equivalent
K023908INTERPORE CROSS CEMENT RESTRICTORJDKUnknown
K022143INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)MQPSubstantially Equivalent
K022048INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEMKWPSubstantially Equivalent
K022348ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000CACSubstantially Equivalent
K012406ACCESS SEQUESTRATION SYSTEMCACSubstantially Equivalent
K020204TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189MQPSubstantially Equivalent
K020048MODIFICATION TO GEO STRUCTUREMQPSubstantially Equivalent
K014145MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131MQPSubstantially Equivalent
K010989TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131MQPSubstantially Equivalent
K012871SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177KWPSubstantially Equivalent
K010530GEO STRUCTUREMQPSubstantially Equivalent
K004003PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30MQVSubstantially Equivalent
K011148ULTRACONCENTRATOR SYSTEMFJISubstantially Equivalent
K011437SYNERGY 4.0 MM, 4.5 MM VLS SCREWSMNISubstantially Equivalent
K010708APPLICATOR TIP/DUAL SPRAYER KITFMFSubstantially Equivalent
K010515MODIFICATION TO SYNERGY SPINAL SYSTEMKWPSubstantially Equivalent
K002592INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K000515PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,MQVSubstantially Equivalent
K000876SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMPMNISubstantially Equivalent
K000236SYNERGY VLS CAP NUT MODELS 2206, 6102MNISubstantially Equivalent
K993808SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220MNHSubstantially Equivalent
K992369SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22MNISubstantially Equivalent
K991854OSTEOPLAST, MODEL POP200MQVSubstantially Equivalent
K990057SYNERGY ADJUSTABLE LENGTH RODMNISubstantially Equivalent
K984578SYNERGY D2 SPINAL IMPLANTSMNISubstantially Equivalent
K990131PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTEMQVSubstantially Equivalent
K982368MANIFOLD WITH EXTENSION SETFMGSubstantially 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