S-Rom(R) Ztt(Tm) Acetabular Cup-Apical Hole Plug
FDA 510(k) K931676 · Joint Medical Products Corp.
510(k) numberK931676
Submission
- Device name
- S-Rom(R) Ztt(Tm) Acetabular Cup-Apical Hole Plug
- Applicant
- Joint Medical Products Corp.
Stamford, CT, US - Received
- April 6, 1993
- Decision date
- May 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| 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 |
|---|---|---|
| K955511 | Arthopor I & II Acetabular Cup/Arthopor II Oblong Acetabular CupLPH · Traditional | 02/26/1996SE |
| K954935 | S-Rom Femoral Hip Stem - Size 14 X 8LPH · Traditional | 01/22/1996SE |
| K944321 | S-Rom Noiles Posterior Stabilized Total Knee System IIJWH · Traditional | 08/14/1995SN |
| K951726 | S-Rom ZTP Uhmwpe Acetabular CupJDI · Traditional | 06/21/1995SE |
| K951084 | S-Rom Opc (One-Piece Cemented) II Femoral Hip ProsthesisJDI · Traditional | 05/31/1995SE |
| K951000 | ZTT I and II Acetabular Cup of the S-Rom Total Hip SystemLPH · Traditional | 04/14/1995SE |
| K941769 | Knee ProthesisJWH · Traditional | 02/01/1995SN |
| K936037 | S-Rom Noiles Cruciate Retaining KneeJWH · Traditional | 10/03/1994SN |
| K934412 | Coated ZT Proximal SleeveLPH · Traditional | 06/03/1994SE |
| K935078 | S-Rom Total Hip Replacement SystemJDG · Traditional | 03/09/1994SN |
Questions and answers
When was S-Rom(R) Ztt(Tm) Acetabular Cup-Apical Hole Plug cleared by the FDA?
S-Rom(R) Ztt(Tm) Acetabular Cup-Apical Hole Plug (K931676) received a 510(k) decision of Substantially Equivalent on May 18, 1994, 407 days after the submission was received.
What is the product code of K931676?
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.