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

Memphis, TN, US

Sofamor Danek USA,Inc. appears in FDA device records in Memphis, TN. FDA records list 42 510(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
42
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 42 510(k) clearances for Sofamor Danek USA,Inc. between 1995 and 2000. The busiest year on record is 1997, with 10. The most recent is 2000, with 2.

Clearances by year, as a table
510(k) clearance decisions for Sofamor Danek USA,Inc., by decision year
YearClearances
19958
19967
199710
19989
19996
20002
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K991031COLORADO II SPINAL SYSTEMMNHSubstantially Equivalent
K984360COLORADO II SPINAL SYSTEMMNHSubstantially Equivalent
K992928CD HORIZON SPINAL SYSTEMMNISubstantially Equivalent
K992110PREMIER ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K991036DANEK PLATE AND SCREW SYSTEMMNHSubstantially Equivalent
K991198DYNA-LOK PLUS SPINAL SYSTEMKWPSubstantially Equivalent
K991364MODIFICATION TO TENOR SPINAL SYSTEM-PLATESMNHSubstantially Equivalent
K981676CD HORIZON SPINAL SYSTEMKWPSubstantially Equivalent
K980184CD SPINAL SYSTEMMNISubstantially Equivalent
K983672DYNA-LOK SPINAL SYSTEMMNISubstantially Equivalent
K983706MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEMKWPSubstantially Equivalent
K982990TSRH SPINAL SYSTEMMNISubstantially Equivalent
K982490TENOR SPINAL SYSTEMKWPSubstantially Equivalent
K982686MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEMMNISubstantially Equivalent
K963642INCL II ENDOSCOPEGWGSubstantially Equivalent
K973854ORION ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent for Some Indications
K974017TIMESH SYSTEMHRSSubstantially Equivalent
K973145TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEMJEYSubstantially Equivalent
K964159CD SPINAL SYSTEMKWPSubstantially Equivalent for Some Indications
K963780DUAL ROD ANTERIOR FIXATOR SYSTEMKWQSubstantially Equivalent
K970806ACPII ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent for Some Indications
K964254TITANIUM LIBERTY POSTERIOR SPINAL SYSTEMKWPSubstantially Equivalent for Some Indications
K965193LIBERTY ANTERIOR SPINAL SYSTEMKWQSubstantially Equivalent
K953076TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEMMRWSubstantially Equivalent
K964623TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEMKWQSubstantially Equivalent for Some Indications
K962708TITANIUM CD HORIZON SPINAL SYSTEMKWPSubstantially Equivalent
K964275ALPHA POSTERIOR SPINAL SYSTEMKWPSubstantially Equivalent
K961633CD HORIZON SPINAL SYSTEMKWPSubstantially Equivalent for Some Indications
K963655CD HORIZON ANTERIOR SPINAL SYSTEMKWQSubstantially Equivalent
K955807COTREL-DUBOUSSET (CD) SPINALKWPSubstantially Equivalent for Some Indications
K955365COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEMKWPSubstantially Equivalent
K950717AUGMENT-T POSTERIOR SPINAL SYSTEMMNHSubstantially Equivalent for Some Indications
K951164CD LIBERTY POSTERIOR SPINCAL SYSTEMKWPSubstantially Equivalent for Some Indications
K954645TITANIUM GDLH POSTERIOR SPINAL SYSTEMKWPSubstantially Equivalent for Some Indications
K955471INCL ENDOSCOPEHRXSubstantially Equivalent for Some Indications
K946087INCLUSICE II(TM) ENDOSCOPEHRXSubstantially Equivalent
K953635TITANIUM DYNA-LOK SPINAL SYSTEMMNHSubstantially Equivalent for Some Indications
K950596GDLH POSTERIOR SPINAL SYSTEMMNHSubstantially Equivalent for Some Indications
K950955PARAGON POSTERIOR SPINAL SYSTEMMNHSubstantially Equivalent for Some Indications
K946348TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)MNHSubstantially Equivalent for Some Indications
K950501DANEK RIGID ARTHROSCOPEHRXSubstantially Equivalent
K950130MICRO-ENDO(TM) INSTRUMENTSHRXSubstantially 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