Gripper II Acetabular Cup
FDA 510(k) K893584 · Joint Medical Products Corp.
510(k) numberK893584
Submission
- Device name
- Gripper II Acetabular Cup
- Applicant
- Joint Medical Products Corp.
Stamford, CT, US - Received
- May 9, 1989
- Decision date
- July 28, 1989
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120595 | Unisyn Plus Hip StemLWJ · Traditional | Consensus Orthopedics, Inc. | 10/12/2012SE |
| K103518 | Trinity Acetabular SystemLWJ · Traditional | Corin USA | 03/09/2011SE |
| K090764 | Novation CFS Press-Fit and Cemented StemsLWJ · Special | Exactech, Inc. | 04/21/2009SE |
| K082146 | Metha Short Stem Hip System XL Femoral HeadLWJ · Special | Aesculap Implant Systems, Inc. | 09/09/2008SE |
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special | Hayes Medical, Inc. | 01/31/2007SE |
| K062978 | U2 Hip Stem, Ti Plasma SprayLWJ · Traditional | United Orthopedic Corp. | 01/16/2007SE |
| K062383 | Unisyn Ha Plasma Modular HipLWJ · Special | Hayes Medical, Inc. | 12/21/2006SE |
| K061699 | ExciaLWJ · Special | Aesculap, Inc. | 08/18/2006SE |
| K051826 | Betacone Hip Prosthesis SystemLWJ · Traditional | Waldemar Link GmbH & Co. KG | 11/18/2005SE |
| K050262 | U2 Acetabular ComponentLWJ · Traditional | United Orthopedic Corp. | 08/15/2005SE |
More from United Orthopedic Corp.
| 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 |
| K931676 | S-Rom(R) Ztt(Tm) Acetabular Cup-Apical Hole PlugJDL · Traditional | 05/18/1994SE |
Questions and answers
When was Gripper II Acetabular Cup cleared by the FDA?
Gripper II Acetabular Cup (K893584) received a 510(k) decision of Substantially Equivalent for Some Indications on July 28, 1989, 80 days after the submission was received.
What is the product code of K893584?
The FDA product code is LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3360.