Baumer Femoral Head

FDA 510(k) K001571 · Baumer, S.A

Substantially Equivalent

510(k) numberK001571

Submission

Device name
Baumer Femoral Head
Applicant
Baumer, S.A
Mogi Mirim, Sao Paulo, BR
Received
May 22, 2000
Decision date
August 4, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3350
Specialty
Orthopedic
Implant
Yes

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K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional Howmedica Osteonics Corp., Dba Stryker…08/02/2024SE
K240418Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional Howmedica Osteonics Corp., Dba Stryker…04/12/2024SE
K233261Global Modular Replacement SystemJDI · Traditional Howmedica Osteonics Corp. A.K.A. Stryker…12/08/2023SE
K222056Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional Howmedica Osteonics Corp., Dba Stryker…01/26/2023SE
K220216C-Stem AMT LE ProsthesisJDI · Traditional Depuy Ireland UC07/22/2022SE

More from Depuy Ireland UC

510(k)DeviceDecision
K011504Baumer Locking NailJDS · Traditional 08/14/2001SE
K003976Baumer Muller Hip ProsthesisJDI · Traditional 03/19/2001SE
K003975Baumer Cemented Hip ProsthesisJDI · Traditional 03/19/2001SE

Questions and answers

When was Baumer Femoral Head cleared by the FDA?

Baumer Femoral Head (K001571) received a 510(k) decision of Substantially Equivalent on August 4, 2000, 74 days after the submission was received.

What is the product code of K001571?

The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.