Ascension Pyrocarbon Lunate
FDA 510(k) K080997 · Ascension Orthopedics, Inc.
510(k) numberK080997
Submission
- Device name
- Ascension Pyrocarbon Lunate
- Applicant
- Ascension Orthopedics, Inc.
Austin, TX, US - Received
- April 8, 2008
- Decision date
- June 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWN – Prosthesis, Wrist, Carpal Lunate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3750
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141920 | Wrist Hemiarthroplasty SystemKWN · Traditional | Arthrosurface, Inc. | 12/23/2014SE |
| K050028 | Maestro Carpal HemiarthroplastyKWN · Traditional | Biomet Manufacturing, Inc. | 03/25/2005SE |
| K864491 | Swanson Titanium Carpal Lunate ImplantKWN · Traditional | Dow Corning Wright | 04/15/1987SE |
| K790793 | Amc R Metacarpal ComponentKWN · Traditional | Howmedica Corp. | 06/22/1979SE |
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| K162153 | Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation SystemHWC · Traditional | 07/14/2017SE |
| K160830 | Integra External Fixation SystemKTT · Special | 07/06/2016SE |
| K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidKWS · Traditional | 12/23/2015SE |
| K152527 | Integra DigiFuse Cannulated Intramedullary Fusion SystemHWC · Traditional | 10/29/2015SE |
| K151459 | Integra Total Ankle Replacement SystemHSN · Traditional | 08/31/2015SE |
| K142413 | TITAN Modular Total Shoulder SystemKWS · Traditional | 11/14/2014SE |
| K121826 | Integra Proximal Humeral Plate SystemHRS · Traditional | 02/13/2013SE |
Questions and answers
When was Ascension Pyrocarbon Lunate cleared by the FDA?
Ascension Pyrocarbon Lunate (K080997) received a 510(k) decision of Substantially Equivalent on June 17, 2008, 70 days after the submission was received.
What is the product code of K080997?
The FDA product code is KWN – Prosthesis, Wrist, Carpal Lunate, a Class II (moderate risk) device regulated under 21 CFR 888.3750.