Baumer Muller Hip Prosthesis

Q: What is the product code of K003976?

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.

FDA 510(k) K003976 · Baumer, S.A

Substantially Equivalent

510(k) numberK003976

Submission

Device name: Baumer Muller Hip Prosthesis
Applicant: Baumer, S.A
Mogi Mirim, Sao Paulo, BR
Received: December 22, 2000
Decision date: March 19, 2001
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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K240783	Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…JDI · Traditional	Smith & Nephew, Inc.	10/21/2024SE
K241716	Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional	Howmedica Osteonics Corp., Dba Stryker…	08/02/2024SE
K240418	Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional	Howmedica Osteonics Corp., Dba Stryker…	04/12/2024SE
K233261	Global Modular Replacement SystemJDI · Traditional	Howmedica Osteonics Corp. A.K.A. Stryker…	12/08/2023SE
K222056	Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional	Howmedica Osteonics Corp., Dba Stryker…	01/26/2023SE
K220216	C-Stem AMT LE ProsthesisJDI · Traditional	Depuy Ireland UC	07/22/2022SE

More from Depuy Ireland UC

510(k)	Device	Decision
K011504	Baumer Locking NailJDS · Traditional	08/14/2001SE
K003975	Baumer Cemented Hip ProsthesisJDI · Traditional	03/19/2001SE
K001571	Baumer Femoral HeadJDI · Traditional	08/04/2000SE

Questions and answers

When was Baumer Muller Hip Prosthesis cleared by the FDA?

Baumer Muller Hip Prosthesis (K003976) received a 510(k) decision of Substantially Equivalent on March 19, 2001, 87 days after the submission was received.

What is the product code of K003976?

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.