Pasco Mic and Mic/Id Panels/ Cefdinir
FDA 510(k) K982156 · Pasco Laboratories, Inc.
510(k) numberK982156
Submission
- Device name
- Pasco Mic and Mic/Id Panels/ Cefdinir
- Applicant
- Pasco Laboratories, Inc.
Wheat Ridge, CO, US - Received
- June 18, 1998
- Decision date
- July 29, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWJ – Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3800
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243381 | Total Wrist Arthroplasty System (TWA)JWJ · Special | Skeletal Dynamics, Inc. | 11/01/2024SE |
| K233574 | Total Wrist Arthroplasty System (TWA)JWJ · Traditional | Skeletal Dynamics | 07/03/2024SE |
| K233674 | Freedom Wrist Arthroplasty SystemJWJ · Traditional | Ascension Orthopedics, Inc. | 05/30/2024SE |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty SystemJWJ · Traditional | Arthrosurface, Inc. | 10/15/2020SE |
| K191525 | KinematX Total Wrist Arthroplasty SystemJWJ · Traditional | Extremity Medical, LLC | 03/04/2020SE |
| K132250 | Integra Freedom Wrist Arthroplasty SystemJWJ · Traditional | Integra LifeSciences Corporation | 03/24/2014SE |
| K080426 | Maestro Wrist Fracture ImplantJWJ · Traditional | Biomet Manufacturing Corp | 07/29/2008SE |
| K042032 | Maestro Total WristJWJ · Traditional | Biomet, Inc. | 10/07/2004SE |
| K031203 | Biax A.F. Wrist/Biax Advanced Fixation WristJWJ · Traditional | DePuy Orthopaedics, Inc. | 07/14/2003SE |
| K030037 | Universal Total Wrist SystemJWJ · Special | Kinetikos Medical, Inc. | 02/05/2003SE |
More from Kinetikos Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K042331 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 10/07/2004SE |
| K041776 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 08/03/2004SE |
| K041214 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 06/07/2004SE |
| K033119 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 11/18/2003SE |
| K031727 | Pasco Mic and Mic/Id Panels, GemifloxacinJWY · Traditional | 07/30/2003SE |
| K031205 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 06/13/2003SE |
| K031103 | Pasco Mic and Mic/Id Panels (Ertapenem)JWY · Traditional | 06/12/2003SE |
| K030933 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 05/01/2003SE |
| K030620 | Pasco Mic and Mic/Id PanelsLTT · Traditional | 04/14/2003SE |
| K020331 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 03/20/2002SE |
Questions and answers
When was Pasco Mic and Mic/Id Panels/ Cefdinir cleared by the FDA?
Pasco Mic and Mic/Id Panels/ Cefdinir (K982156) received a 510(k) decision of Substantially Equivalent on July 29, 1998, 41 days after the submission was received.
What is the product code of K982156?
The FDA product code is JWJ – Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained, a Class II (moderate risk) device regulated under 21 CFR 888.3800.