Stryker Femoral Canal Brush, Acetabular Brush
FDA 510(k) K941605 · Stryker Corp.
510(k) numberK941605
Submission
- Device name
- Stryker Femoral Canal Brush, Acetabular Brush
- Applicant
- Stryker Corp.
Kalamazoo, MI, US - Received
- April 1, 1994
- Decision date
- August 5, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K101609 | Self Retaining Soft Tissue RetractorLXH · Traditional | Koros USA, Inc. | 12/09/2010SE |
| K001507 | Microperforation InstrumentLXH · Traditional | Smith & Nephew, Inc. | 06/14/2000SE |
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | Orthopedic Systems, Inc. | 01/22/1996SE |
| K943873 | Orthomet Anatomically Guided Carpal Tunnel Release SyLXH · Traditional | Orthomet, Inc. | 04/26/1995SE |
| 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 |
| K933772 | Punch SurgicalLXH · Traditional | Mahe-Medizintechnik | 02/01/1994SE |
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Questions and answers
When was Stryker Femoral Canal Brush, Acetabular Brush cleared by the FDA?
Stryker Femoral Canal Brush, Acetabular Brush (K941605) received a 510(k) decision of Substantially Equivalent on August 5, 1994, 126 days after the submission was received.
What is the product code of K941605?
The FDA product code is LXH – Orthopedic Manual Surgical Instrument, a Class I (low risk) device regulated under 21 CFR 888.4540.