Orthomet Anatomically Guided Carpal Tunnel Release Sy
FDA 510(k) K943873 · Orthomet, Inc.
510(k) numberK943873
Submission
- Device name
- Orthomet Anatomically Guided Carpal Tunnel Release Sy
- Applicant
- Orthomet, Inc.
Minneapolis, MN, US - Received
- August 9, 1994
- Decision date
- April 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
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| K001507 | Microperforation InstrumentLXH · Traditional | Smith & Nephew, Inc. | 06/14/2000SE |
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | Orthopedic Systems, Inc. | 01/22/1996SE |
| K944188 | Spinal MarkerLXH · Traditional | Leibinger L.P. | 04/13/1995SE |
| K941896 | Steadman Ligament Graft Passer and ProtectorLXH · Traditional | Depuy, Inc. | 11/07/1994SE |
| K941711 | Hyperflex Flexible GuidewiresLXH · Traditional | Linvatec Corp. | 08/26/1994SE |
| K941605 | Stryker Femoral Canal Brush, Acetabular BrushLXH · Traditional | Stryker Corp. | 08/05/1994SE |
| K933772 | Punch SurgicalLXH · Traditional | Mahe-Medizintechnik | 02/01/1994SE |
More from Mahe-Medizintechnik
| 510(k) | Device | Decision |
|---|---|---|
| K936310 | Orthomet HMC Femoral Stem ComponentLPH · Traditional | 06/07/1995SE |
| K945783 | Orthomet Titanium Hybrid Femoral StemJDG · Traditional | 05/30/1995SE |
| 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 |
| K931678 | Orthomet LHMC Femoral StemHMC · 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 Anatomically Guided Carpal Tunnel Release Sy cleared by the FDA?
Orthomet Anatomically Guided Carpal Tunnel Release Sy (K943873) received a 510(k) decision of Substantially Equivalent on April 26, 1995, 260 days after the submission was received.
What is the product code of K943873?
The FDA product code is LXH – Orthopedic Manual Surgical Instrument, a Class I (low risk) device regulated under 21 CFR 888.4540.