Transfx Multi Pin Clamp
FDA 510(k) K991723 · Immedica, Inc.
510(k) numberK991723
Submission
- Device name
- Transfx Multi Pin Clamp
- Applicant
- Immedica, Inc.
Chatham, NJ, US - Received
- May 20, 1999
- Decision date
- July 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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More from Hand Innovations, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K023575 | Concert CranioplastGXP · Traditional | 01/22/2003SE |
| K013755 | Concert Radiopaque Bone CementLOD · Traditional | 02/08/2002SE |
| K003205 | Transfx Angled RodsLXT · Traditional | 12/15/2000SE |
| K001228 | External Fixation Anchor PinJDW · Traditional | 07/07/2000SE |
| K001084 | Trans FX Adjustable Pin to Bar ClampLXT · Traditional | 06/15/2000SE |
| K990848 | Transfx Intermediate External Fixation System,Transfx Small External Fixation System…LXT · Traditional | 05/17/1999SE |
| K984357 | Transfx External Fixation SystemLXT · Traditional | 03/04/1999SE |
Questions and answers
When was Transfx Multi Pin Clamp cleared by the FDA?
Transfx Multi Pin Clamp (K991723) received a 510(k) decision of Substantially Equivalent on July 22, 1999, 63 days after the submission was received.
What is the product code of K991723?
The FDA product code is LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite, a Class II (moderate risk) device regulated under 21 CFR 888.3030.