510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Danek Medical, Inc.

Mchenry, IL, US

Danek Medical, Inc. appears in FDA device records in Mchenry, IL. FDA records list 56 510(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
56
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 56

FDA records hold 56 510(k) clearances for Danek Medical, Inc. between 1981 and 2000. The busiest year on record is 1983, with 14. The most recent is 2000, with 2.

Clearances by year, as a table
510(k) clearance decisions for Danek Medical, Inc., by decision year
YearClearances
19811
198314
19851
19894
199012
19917
19922
19931
19943
19951
19961
19982
19995
20002
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K994122BONE GRAFT WASHER, MODEL 9090114 - 9090118KWQSubstantially Equivalent
K993810CD HORIZON SPINAL SYSTEMMNHSubstantially Equivalent
K993855ATLANTIS ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K991528MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTORMNHSubstantially Equivalent
K990603MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEMKWQSubstantially Equivalent
K982875MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEMKWQSubstantially Equivalent
K984522MODIFICATION OF TSRH SPINAL SYSTEMMNISubstantially Equivalent
K982154MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEMMNISubstantially Equivalent
K970599TOWNLEY PEDICLE SCREW PLATING SYSTEMMNISubstantially Equivalent
K943827SPINE FIXATIONMNHSubstantially Equivalent for Some Indications
K943356INCLUSIVE ENDOSCOPEHRXSubstantially Equivalent
K943676DANEKSCOPE OPTI-PROBEHRXSubstantially Equivalent
K933205TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGONKWPSubstantially Equivalent for Some Indications
K933242SOFAMOR ORTHOPAEDIC INSTRUMENTSLXHSubstantially Equivalent
K911729DANEKSCOPE AND ACCESSORIESHRXSubstantially Equivalent
K901692DANEK SPINALSCOPEHRXSubstantially Equivalent
K904243TSRH VARIABLE ANGLE SACRAL SCREWKWPSubstantially Equivalent for Some Indications
K913735SONGER(TM) CABLE SYSTEMJDQSubstantially Equivalent
K904520RAY SACRAL FIXATION SYSTEMKWPSubstantially Equivalent for Some Indications
K911307CROSSLINK PLATEKWPSubstantially Equivalent
K911379DANEK SACRAL HOOK, MODIFICATIONKWPSubstantially Equivalent
K911306T-BOLT AND NUTHTNSubstantially Equivalent
K911319TSRH OPEN HEAD BONE SCREWKWPSubstantially Equivalent
K911300MICROSURGICAL INSTRUMENTSHRXSubstantially Equivalent
K902775KNIGHT SACRAL SCREWKWPSubstantially Equivalent for Some Indications
K901005TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)KWPSubstantially Equivalent for Some Indications
K903461TSRH OFFSET AND SIDE-LOADING HOOKSKWPSubstantially Equivalent for Some Indications
K901587TSRH SACRAL L-CONNECTORKWPSubstantially Equivalent for Some Indications
K903676STERNOTOMY CABLE, SONGER CABLE SYSTEMJDQSubstantially Equivalent
K903105OLIVE K-WIRESJECSubstantially Equivalent
K901590DANEK SACRAL HOOKKWPSubstantially Equivalent for Some Indications
K895978CHIBA SPINAL SYSTEMKWPSubstantially Equivalent
K896254DANEK PRECISION ROD SETKWPSubstantially Equivalent
K896740AXIAL AND OFFSET CROSSLINK PLATESKWPSubstantially Equivalent
K896603HSC UNIT RODKWPSubstantially Equivalent
K890192LUQUE III SPINAL SYSTEM AND LUQUE MINI-SETKWPSubstantially Equivalent
K891066DANEK WRIST FIXATORKTTSubstantially Equivalent
K892651SONGER WIRING SYSTEMLRNSubstantially Equivalent
K890814DANEK RING FIXATOR (DRF)KTTSubstantially Equivalent
K890090DANEK IRRIGATING BURR (DIB) SETGFFSubstantially Equivalent
K843227MACULAR FUNCTION ANALYZERHOQSubstantially Equivalent
K823821SIDE RAIL PADSFNJSubstantially Equivalent
K823823LUMBOSACRAL SUPPORTIPYSubstantially Equivalent
K823822ANKLE WEIGHTSIODSubstantially Equivalent
K823820ABDUCTION PILLOWIOZSubstantially Equivalent
K823819CAST TOE COVERLGFSubstantially Equivalent
K823816WHEELCHAIR PATIENT RESTRAINTSKNOSubstantially Equivalent
K823814HOT/COLD PACK HOLDERSIMESubstantially Equivalent
K823813TRACTION ACCESSORIESHSTSubstantially Equivalent
K823812VARIOUS SUPPORTS AND SPLINTSIQISubstantially 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.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Danek Medical, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Danek Medical, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

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