Atlas FDA

DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)

FDA 510(k) clearance K032331 · decided 2003-11-20

Clearance details

K-number
K032331
Device name
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
Applicant
Pro-Med Instruments GmbH
Decision
Substantially Equivalent
Date received
2003-07-29
Decision date
2003-11-20
Days to decision
114 days
Clearance type
Traditional
Product code
HBL
Device class
2
Regulation number
882.4460
Medical specialty
Neurology
Advisory committee
Neurology
Location
Alva, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous cranioto recall (Z-2970-2018)Pro-Med Instruments Gmbh2018-09-17
DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in recall (Z-2971-2018)Pro-Med Instruments Gmbh2018-09-17
DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open an recall (Z-2972-2018)Pro-Med Instruments Gmbh2018-09-17