ClearanceBrief
Company

Bock,Otto,Orthopedic Ind,Inc

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
IMPCushion, Wheelchair1
IORWheelchair, Mechanical1
ISHComponent, External, Limb, Ankle/Foot1
ISYJoint, Knee, External Limb Component1
KFXAssembly, Thigh/Knee/Shank/Ankle/Foot, External1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 21, 2014Bock,Otto,Orthopedic Ind,Inc
Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following mate
Terminated
IMPNone listed
Dec 16, 2009Bock,Otto,Orthopedic Ind,Inc
Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. Pediatric Prosthetic Device used by Lower Limb amputees.
Terminated
ISYNone listed
Jan 25, 2007Bock,Otto,Orthopedic Ind,Inc
Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint u
Terminated
KFXK991590
Aug 18, 2004Bock,Otto,Orthopedic Ind,Inc
Modular Knee Joint with Friction Brake
Terminated
ISHNone listed
Jul 20, 2004Bock,Otto,Orthopedic Ind,Inc
Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_
Terminated
IORNone listed
Get alerts for these product codes