Cohn Targeteer
FDA 510(k) K891903 · Orthopedic Systems, Inc.
510(k) numberK891903
Submission
- Device name
- Cohn Targeteer
- Applicant
- Orthopedic Systems, Inc.
Hayward, CA, US - Received
- March 27, 1989
- Decision date
- May 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| K192873 | SX-One MicroKnifeLXH · Traditional | Sonex Health, Inc. | 12/20/2019SE |
| K140414 | Imbibe NeedleLXH · Traditional | Orthovita, Inc. | 04/01/2014SE |
| 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 |
| K941605 | Stryker Femoral Canal Brush, Acetabular BrushLXH · Traditional | Stryker Corp. | 08/05/1994SE |
More from Stryker Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | 01/22/1996SE |
| K920256 | Spine Motion Analyzer with EmgKQX · Traditional | 08/10/1992SE |
| K910736 | Jackson Multipurpose Operating TableJEA · Traditional | 05/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | 01/24/1991SE |
| K903938 | C Fit CupJDI · Traditional | 01/04/1991SN |
| K892503 | Nuffield Total KneeJWH · Traditional | 05/04/1990SN |
| K896678 | Silicone PlugHRX · Traditional | 01/30/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
| K890498 | Freeman Modular Hip Stem Ridged VersionJDI · Traditional | 10/13/1989SN |
| K890331 | Freeman Total Hip System Ridged StemLWJ · Traditional | 10/13/1989SE |
Questions and answers
When was Cohn Targeteer cleared by the FDA?
Cohn Targeteer (K891903) received a 510(k) decision of Substantially Equivalent on May 15, 1989, 49 days after the submission was received.
What is the product code of K891903?
The FDA product code is LXH – Orthopedic Manual Surgical Instrument, a Class I (low risk) device regulated under 21 CFR 888.4540.