Kronner Sacral Pin Guide
FDA 510(k) K895172 · Kronner Medical
510(k) numberK895172
Submission
- Device name
- Kronner Sacral Pin Guide
- Applicant
- Kronner Medical
Roseburg, OR, US - Received
- August 10, 1989
- Decision date
- September 12, 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
Other 510(k)s with product code LXH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K894228 | Kronner Spherical CuttersHWT · Traditional | 07/23/1990SE |
| K895171 | Blood Gas Safety SyringeCBT · Traditional | 11/07/1989SE |
| K895173 | Skeletal Fixation PinJDW · Traditional | 09/12/1989SE |
| K871248 | Kronner Colles-Forearm External FixationKTT · Traditional | 06/03/1987SE |
| K871249 | Kronner Bi-Planer Tibia External FixationKTT · Traditional | 05/22/1987SE |
| K871247 | Kronner Universal Frame External FixationKTT · Traditional | 05/22/1987SE |
Questions and answers
When was Kronner Sacral Pin Guide cleared by the FDA?
Kronner Sacral Pin Guide (K895172) received a 510(k) decision of Substantially Equivalent on September 12, 1989, 33 days after the submission was received.
What is the product code of K895172?
The FDA product code is LXH – Orthopedic Manual Surgical Instrument, a Class I (low risk) device regulated under 21 CFR 888.4540.