Spinal Distractors, Spanners
FDA 510(k) K882069 · Karlin Technology, Inc.
510(k) numberK882069
Submission
- Device name
- Spinal Distractors, Spanners
- Applicant
- Karlin Technology, Inc.
Marina Del Rey, CA, US - Received
- May 17, 1988
- Decision date
- June 17, 1988
- 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 |
|---|---|---|
| K903969 | Suction Retractor(Tower Attach.)For Crank Fram RetGAD · Traditional | 09/05/1990SE |
| K893203 | Bone ScrewJDR · Traditional | 04/04/1990SE |
| K893201 | Bone PlateHRS · Traditional | 04/04/1990SE |
| K882525 | Spinal MicroknifeHTS · Traditional | 09/22/1988SE |
| K882519 | X-Ray MarkerJAC · Traditional | 08/09/1988SE |
| K882520 | Shoulder Bolster, Knee, Ankle & Leg Support PadsLWG · Traditional | 07/18/1988SE |
| K882073 | Spinal NeedleGDM · Traditional | 07/18/1988SE |
| K882524 | Universally Adjustable ArmboardBTX · Traditional | 07/08/1988SE |
| K882077 | Microdiscectomy CurrettesLXH · Traditional | 06/17/1988SE |
| K882072 | Orthopaedic and Spinal Ring CurrettesJXH · Traditional | 06/17/1988SE |
Questions and answers
When was Spinal Distractors, Spanners cleared by the FDA?
Spinal Distractors, Spanners (K882069) received a 510(k) decision of Substantially Equivalent on June 17, 1988, 31 days after the submission was received.
What is the product code of K882069?
The FDA product code is LXH – Orthopedic Manual Surgical Instrument, a Class I (low risk) device regulated under 21 CFR 888.4540.