Atlas FDA

STABLELOC II EXTERNAL FIXATOR

FDA 510(k) clearance K965029 · decided 1997-02-19

Clearance details

K-number
K965029
Device name
STABLELOC II EXTERNAL FIXATOR
Applicant
Acu Med, Inc.
Decision
Substantially Equivalent
Date received
1996-12-17
Decision date
1997-02-19
Days to decision
64 days
Clearance type
Traditional
Product code
JEC
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Beaverton, OR, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wr recall (Z-1154-2010)Acumed LLC2010-03-16