Femoral Heads/Modular & Fixed W/ Titan Nitride Sur
FDA 510(k) K892059 · Protek, Inc.
510(k) numberK892059
Submission
- Device name
- Femoral Heads/Modular & Fixed W/ Titan Nitride Sur
- Applicant
- Protek, Inc.
Indianapolis, IN, US - Received
- March 29, 1989
- Decision date
- July 19, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LZY – Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LZY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231448 | TANDEM Hip SystemLZY · Traditional | Smith & Nephew, Inc. | 07/19/2023SE |
| K111145 | Endo HeadLZY · Traditional | Medacta International | 08/16/2011SE |
| K974442 | Pre-Powdered Nitrile Examination GlovesLZY · Traditional | P.T. Latexindo Tobaperkasa | 01/05/1998SE |
| K915528 | BHR Bipolar Femoral Head ComponentLZY · Traditional | Implantology Corp. | 06/29/1993SE |
| K915548 | Ionguard Titanium Modular HeadsLZY · Traditional | Biomet, Inc. | 03/10/1992SE |
| K903084 | Modular Cathcart Fracture SystemLZY · Traditional | Depuy, Inc. | 10/03/1990SE |
| K896580 | Uni-Polar HeadLZY · Traditional | Richards Medical Co., Inc. | 02/15/1990SE |
More from Richards Medical Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893785 | ARC-2F Acetabular CupLWJ · Traditional | 08/09/1989SN |
| K893959 | P.S.A. Femoral Hip ProsthesisKWY · Traditional | 07/25/1989SE |
| K883794 | Resubmitted CLW Acetabular Cup W/SulmeshLWJ · Traditional | 05/26/1989SE |
| K884952 | Various Femoral Hip Prostheses W/Self Lock CeramicLZO · Traditional | 05/10/1989SE |
| K884889 | Modified O.E.C. Univ. Self-Aligning Aceta. Comp.KWL · Traditional | 02/27/1989SE |
| K890054 | M.E.M. Acetabular Cup W/Sulmesh for Cement Appli.JDI · Traditional | 02/08/1989SN |
| K884789 | New Jersey Femoral Hip Prosthesis for Cement AppliKWL · Traditional | 02/08/1989SN |
| K884888 | Modified New Jersey Acetabular Comp. & Bone ScrewsJDI · Traditional | 12/29/1988SN |
| K882671 | Samuelson Screwloc CupKWA · Traditional | 10/20/1988SE |
| K874093 | SLS-88 Total Hip System, Acetabular CupJDI · Traditional | 01/27/1988SE |
Questions and answers
When was Femoral Heads/Modular & Fixed W/ Titan Nitride Sur cleared by the FDA?
Femoral Heads/Modular & Fixed W/ Titan Nitride Sur (K892059) received a 510(k) decision of Substantially Equivalent on July 19, 1989, 112 days after the submission was received.
What is the product code of K892059?
The FDA product code is LZY – Prosthesis, Hip, Hemi-, Femoral, Metal Ball, a Class II (moderate risk) device regulated under 21 CFR 888.3360.