Orthomet LHMC Femoral Stem
FDA 510(k) K931678 · Orthomet, Inc.
510(k) numberK931678
Submission
- Device name
- Orthomet LHMC Femoral Stem
- Applicant
- Orthomet, Inc.
Minneapolis, MN, US - Received
- April 6, 1993
- Decision date
- October 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HMC – Monitor, Eye Movement, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1510
- Specialty
- Ophthalmic
More from Orthomet, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K936310 | Orthomet HMC Femoral Stem ComponentLPH · Traditional | 06/07/1995SE |
| K945783 | Orthomet Titanium Hybrid Femoral StemJDG · Traditional | 05/30/1995SE |
| K943873 | Orthomet Anatomically Guided Carpal Tunnel Release SyLXH · Traditional | 04/26/1995SE |
| K944752 | Orthomet Resurfacing Femoral ComponentKXA · Traditional | 12/28/1994SE |
| K930771 | Perfecta Total Hip System Coated Cocr Femoral StemJDI · Traditional | 11/30/1994SN |
| K926334 | Axiom Total Knee Syst/Acl Retain Tibial Tray/InserJWH · Traditional | 10/18/1994SN |
| K932677 | Axiom Total Knee SystemJWH · Traditional | 10/14/1994SE |
| K931333 | Orthomet Acetabular Cup SystemLPH · Traditional | 10/14/1994SE |
| K925536 | Hybrid Femoral Stem, Perfecta Total Hip SystemKWY · Traditional | 01/07/1994SN |
| K923243 | Perfecta Total Hip SystemJDI · Traditional | 01/07/1994SE |
Questions and answers
When was Orthomet LHMC Femoral Stem cleared by the FDA?
Orthomet LHMC Femoral Stem (K931678) received a 510(k) decision of Substantially Equivalent on October 14, 1994, 556 days after the submission was received.
What is the product code of K931678?
The FDA product code is HMC – Monitor, Eye Movement, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 886.1510.