510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Disc-O-Tech Medical Technologies, Ltd.

Washington, DC, US

Disc-O-Tech Medical Technologies, Ltd. appears in FDA device records in Washington, DC. FDA records list 16 510(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
16
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 16 510(k) clearances for Disc-O-Tech Medical Technologies, Ltd. between 2001 and 2007. The busiest year on record is 2001, with 4. The most recent is 2007, with 2.

Clearances by year, as a table
510(k) clearance decisions for Disc-O-Tech Medical Technologies, Ltd., by decision year
YearClearances
20014
20021
20032
20044
20063
20072
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K071375MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)NDNSubstantially Equivalent
K071679METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMSHSBSubstantially Equivalent
K063067CONFIDENCE FENESTRATED INTRODUCER NEEDLENDNSubstantially Equivalent
K062424CONFIDENCE EX HIGH VISCOSITY BONE CEMENTNDNSubstantially Equivalent
K060300CONFIDENCE HIGH VISCOSITY BONE CEMENTNDNSubstantially Equivalent
K040612SKY BONE EXPANDER SYSTEM (SKY SYSTEM)HRXSubstantially Equivalent
K040939SKY BONE EXPANDER SYSTEM (SKY SYSTEM)HRXSubstantially Equivalent
K032730FIXION HIP SYSTEMJDISubstantially Equivalent
K034037SKY BONE EXPANDER SYSTEMHRXSubstantially Equivalent
K032358B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)HRXSubstantially Equivalent
K030972FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)KWLSubstantially Equivalent
K014072FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)KWYSubstantially Equivalent
K013449MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEMHSBSubstantially Equivalent
K010988FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEMHSBSubstantially Equivalent
K010901FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL BHSBSubstantially Equivalent
K011390BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEMMBISubstantially 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