Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating
FDA 510(k) K081876 · Osteomed LP
510(k) numberK081876
Submission
- Device name
- Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating
- Applicant
- Osteomed LP
Addison, TX, US - Received
- July 2, 2008
- Decision date
- August 1, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWD – Prosthesis, Toe, Hemi-, Phalangeal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3730
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K250074 | HYALEX® MTP Hemiarthroplasty ImplantKWD · Traditional | Hyalex Orthopaedics, Inc. | 04/03/2026SE |
| K240268 | Accu-Joint Hemi ImplantKWD · Special | Accufix Surgical, Inc. | 02/29/2024SE |
| K221220 | Montross Extremity Medical Hemi Implant SystemKWD · Traditional | Montross Extremity Medical | 04/19/2023SE |
| K222964 | BioPoly Lesser Toe Hemiarthroplasty ImplantKWD · Traditional | BioPoly, LLC | 11/22/2022SE |
| K201393 | restor3d MTP ImplantKWD · Traditional | Restor3D, Inc. | 05/25/2022SE |
| K203634 | BioPoly Great Toe Hemiarthroplasty ImplantKWD · Traditional | BioPoly, LLC | 02/02/2021SE |
| K200951 | Accu-Joint Hemi ImplantKWD · Traditional | Accufix Surgical, Inc. | 12/08/2020SE |
| K190261 | BOSS Toe Fixation SystemKWD · Traditional | Arthrosurface, Inc. | 08/14/2019SE |
| K190543 | Cannulated Hemi ImplantKWD · Traditional | Vilex IN Tennessee, Inc. | 05/31/2019SE |
| K161279 | Life Spine Metatarsal Hemi ImplantKWD · Traditional | Life Spine, Inc. | 02/01/2017SE |
More from Life Spine, 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 Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating cleared by the FDA?
Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating (K081876) received a 510(k) decision of Substantially Equivalent on August 1, 2008, 30 days after the submission was received.
What is the product code of K081876?
The FDA product code is KWD – Prosthesis, Toe, Hemi-, Phalangeal, a Class II (moderate risk) device regulated under 21 CFR 888.3730.