Metatarsophalangeal Flexible Stabilizing Rod System
FDA 510(k) K022886 · Osteomed Corp.
510(k) numberK022886
Submission
- Device name
- Metatarsophalangeal Flexible Stabilizing Rod System
- Applicant
- Osteomed Corp.
Addison, TX, US - Received
- August 30, 2002
- Decision date
- November 25, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWH – Prosthesis, Toe, Constrained, Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3720
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWH
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|---|---|---|---|
| K191966 | NewPrim SystemKWH · Traditional | Brm Extremities | 02/13/2020SE |
| K190136 | Fusion Silastic SystemKWH · Traditional | Fusion Orthopedics, LLC | 10/21/2019SE |
| K173491 | RTS Lesser MTP Implant SystemKWH · Traditional | In2bones USA, LLC | 02/23/2018SE |
| K153609 | RTS Flexible 1 MPJ Implant w/GrommetsKWH · Traditional | In2bones USA, LLC | 09/08/2016SE |
| K102601 | Orthoflex RodKWH · Traditional | Ortho-Pro, LLC | 01/14/2011SE |
| K023531 | Lesser Metatarsal Phalangeal Joint ImplantKWH · Traditional | Nexa Orthopedics, Inc. | 01/17/2003SE |
| K022887 | Interphalangeal Flexible Stabilizing Rod SystemKWH · Traditional | Osteomed Corp. | 11/26/2002SE |
| K023562 | Modification to Classic Great Toe ImplantKWH · Special | Nexa Orthopedics, Inc. | 11/13/2002SE |
| K023086 | Classic Great Toe ImplantKWH · Special | Nexa Orthopedics, Inc. | 10/04/2002SE |
| K994326 | Ascent Knee SystemKWH · Special | Biomet Manufacturing, Inc. | 01/07/2000SE |
More from Biomet Manufacturing, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212570 | OsteoPlan SystemDZJ · Traditional | 02/11/2022SE |
| K203479 | ExtremiLOCK Lateral Ankle Fusion PlatesHRS · Traditional | 02/24/2021SE |
| K202105 | OsteoMed ExtremiFix Mini & Small System TrayKCT · Traditional | 10/29/2020SE |
| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemHWC · Special | 10/15/2020SE |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization TrayKCT · Traditional | 05/10/2018SE |
| K162542 | OsteoMed PINNACLE DriverHBE · Traditional | 05/19/2017SE |
| K163303 | OsteoMed ExtremiFix Mid and Large Screw SystemHWC · Traditional | 04/04/2017SE |
| K162544 | OsteoMed PINNACLE DriverKMW · Traditional | 04/04/2017SE |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Special | 05/19/2016SE |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Traditional | 12/21/2015SE |
Questions and answers
When was Metatarsophalangeal Flexible Stabilizing Rod System cleared by the FDA?
Metatarsophalangeal Flexible Stabilizing Rod System (K022886) received a 510(k) decision of Substantially Equivalent on November 25, 2002, 87 days after the submission was received.
What is the product code of K022886?
The FDA product code is KWH – Prosthesis, Toe, Constrained, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3720.