Pca(R) Solid Back Acetabula Shell

Q: What is the product code of K930833?

The FDA product code is JDL – Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3320.

FDA 510(k) K930833 · Howmedica Corp.

Substantially Equivalent

510(k) numberK930833

Submission

Device name: Pca(R) Solid Back Acetabula Shell
Applicant: Howmedica Corp.
Rutherford, NJ, US
Received: February 17, 1993
Decision date: February 22, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JDL – Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device class: Class III (high risk)
Regulation: 21 CFR 888.3320
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code JDL

510(k)	Device	Applicant	Decision
K073499	Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesJDL · Traditional	Zimmer, Inc.	08/07/2008SE
K070785	Dynasty Acetabular SystemJDL · Special	Wrightmedicaltechnologyinc	07/11/2007SE
K061844	Dynasty Acetabular Shell and Cocr Acetabular LinerJDL · Special	Wrightmedicaltechnologyinc	12/06/2006SE
K051995	Profemur Renaissance Hip StemJDL · Special	Wrightmedicaltechnologyinc	08/22/2005SE
K051348	Conserve Total Femoral HeadJDL · Traditional	Wrightmedicaltechnologyinc	08/19/2005SE
K042841	M2A/C2A Acetabular SystemJDL · Traditional	Biomet, Inc.	12/21/2004SE
K041586	Profemur S Hip StemJDL · Special	Wrightmedicaltechnologyinc	07/09/2004SE
K041114	Profemur Tapered Hip StemJDL · Special	Wrightmedicaltechnologyinc	05/28/2004SE
K004043	Metal Transcend Articulation SystemJDL · Abbreviated	Wrightmedicaltechnologyinc	07/13/2001SE
K950542	Metal Backed Acetabular ComponentJDL · Traditional	Encore Orthopedics, Inc.	05/25/1995SE

More from Encore Orthopedics, Inc.

510(k)	Device	Decision
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K984202	Howmedica Humeral Intercalary SystemHSD · Traditional	02/05/1999SE
K984305	Zeta Multizone Locking Nail SystemHSB · Traditional	02/01/1999SE
K983885	Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional	01/29/1999SE
K983528	Micro Dynamic MeshJEY · Traditional	12/23/1998SE
K983404	Type 3 Femoral ComponentsLZO · Traditional	12/22/1998SE
K980926	Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional	12/16/1998SE
K980925	Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional	12/16/1998SE
K980632	Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional	12/11/1998SE
K980626	Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional	12/11/1998SE

Questions and answers

When was Pca(R) Solid Back Acetabula Shell cleared by the FDA?

Pca(R) Solid Back Acetabula Shell (K930833) received a 510(k) decision of Substantially Equivalent on February 22, 1994, 370 days after the submission was received.

What is the product code of K930833?

The FDA product code is JDL – Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3320.