Buechel-Pappas Modular Salvage Stem

Q: What is the product code of K982418?

The FDA product code is MJT – Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented, a Class III (high risk) device.

FDA 510(k) K982418 · Endotec, Inc.

Substantially Equivalent

510(k) numberK982418

Submission

Device name: Buechel-Pappas Modular Salvage Stem
Applicant: Endotec, Inc.
South Orange, NJ, US
Received: July 13, 1998
Decision date: April 29, 1999
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: MJT – Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
Device class: Class III (high risk)
Implant: Yes

Other 510(k)s with product code MJT

510(k)	Device	Applicant	Decision
K990712	Osteonics Solar Shoulder Bipolar SystemMJT · Traditional	Howmedica Osteonics Corp.	07/20/1999SE
K960363	Bipolar Shoulder PROSTHESIS-SHELL(RD-113130/33, Biangular Modular…MJT · Traditional	Biomet, Inc.	02/18/1997SE

More from Biomet, Inc.

510(k)	Device	Decision
K081400	Fanning-Pappas Modular Knee BearingJWH · Traditional	02/20/2009SE
K012702	Buechel-Pappas (B-P) Fixed Bearing New Jersey (NJ) Total Knee, Model 1JWH · Traditional	01/30/2002SE
K992394	Buechel-Pappas Humeral Head Resurfacing ComponentHSD · Traditional	10/15/1999SE
K963101	B-P Hemispherical Acetabular ComponentLPH · Traditional	02/12/1997SE
K963100	Tronzo Acetabular Fixation Component (1 99-02-00XX (Ace. Fixation Cup) Xx=Od of Ace. CupLPH · Traditional	02/12/1997SE
K960425	Buechel-Pappas Polyethlene Acetabular COMPONENT(01-42-YYXX & 01-43-YYXXJDI · Traditional	10/03/1996SE
K960424	Buechel-Pappas Polyethylene Glenoid Component (02-11-YYXX) Note:Yy=Id & Xx=OdKWT · Traditional	08/26/1996SE
K945254	Electrosurgical Cutting & Coagulation Device AccessoriesGEI · Traditional	06/06/1995SE
K944465	Carrier, Ligature (79 Gej)GCJ · Traditional	09/28/1994SE
K944414	DekalbGCJ · Traditional	09/27/1994SE

Questions and answers

When was Buechel-Pappas Modular Salvage Stem cleared by the FDA?

Buechel-Pappas Modular Salvage Stem (K982418) received a 510(k) decision of Substantially Equivalent on April 29, 1999, 290 days after the submission was received.

What is the product code of K982418?

The FDA product code is MJT – Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented, a Class III (high risk) device.