G2 Total Hip System Femoral Stem (11/13 Taper)
FDA 510(k) K982812 · Johnson & Johnson Professionals, Inc.
510(k) numberK982812
Submission
- Device name
- G2 Total Hip System Femoral Stem (11/13 Taper)
- Applicant
- Johnson & Johnson Professionals, Inc.
Raynham, MA, US - Received
- August 11, 1998
- Decision date
- December 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
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| K992173 | Siphonguard CSF Control DeviceJXG · Traditional | 04/07/2000SE |
| K991413 | Codman Ethisorb Dura PatchGXQ · Traditional | 03/13/2000SE |
| K991222 | Codman Microsensor Ventricular Catheter KitGWM · Traditional | 07/09/1999SE |
| K982379 | Sundt Slim-Line Aneurysm Clip ApplierHCI · Traditional | 12/18/1998SE |
| K983141 | Capitello-Condylar Total Elbow ProsthesisJDB · Traditional | 11/06/1998SE |
| K983014 | Summit Acetabular SystemLPH · Traditional | 10/27/1998SE |
| K980778 | Hakim Micro Programmable Valve SystemJXG · Traditional | 07/17/1998SE |
| K974739 | Hakim Programmable Valve SystemJXG · Traditional | 07/01/1998SE |
| K980801 | J-Fx Bipolar HeadKWY · Traditional | 05/29/1998SE |
| K980081 | S-Rom Zirconia Ceramic Femoral Hip HeadLZO · Traditional | 04/09/1998SE |
Questions and answers
When was G2 Total Hip System Femoral Stem (11/13 Taper) cleared by the FDA?
G2 Total Hip System Femoral Stem (11/13 Taper) (K982812) received a 510(k) decision of Substantially Equivalent on December 4, 1998, 115 days after the submission was received.
What is the product code of K982812?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.