Classic Great Toe Implant
FDA 510(k) K023086 · Nexa Orthopedics, Inc.
510(k) numberK023086
Submission
- Device name
- Classic Great Toe Implant
- Applicant
- Nexa Orthopedics, Inc.
Vista, CA, US - Received
- September 17, 2002
- Decision date
- October 4, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K022886 | Metatarsophalangeal Flexible Stabilizing Rod SystemKWH · Traditional | Osteomed Corp. | 11/25/2002SE |
| K023562 | Modification to Classic Great Toe ImplantKWH · Special | Nexa Orthopedics, Inc. | 11/13/2002SE |
| K994326 | Ascent Knee SystemKWH · Special | Biomet Manufacturing, Inc. | 01/07/2000SE |
More from Biomet Manufacturing, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K072710 | Nexfix Compression PinJDW · Traditional | 11/08/2007SE |
| K071147 | Nexa Orthopedics Total Shoulder SystemKWT · Traditional | 07/20/2007SE |
| K070688 | Nexfix Compression StapleJDR · Traditional | 05/18/2007SE |
| K060386 | Nexa Carpo Metacarpal ImplantKYI · Traditional | 05/10/2006SE |
| K060071 | Nexa Compression ScrewHWC · Traditional | 01/26/2006SE |
| K053408 | Nexa Bone Plate and Screw SystemHRS · Traditional | 12/22/2005SE |
| K053394 | Nexa Bone Screw SystemHWC · Traditional | 12/14/2005SE |
| K051740 | Tapered Compression PinJDW · Traditional | 09/06/2005SE |
| K051406 | Osteocure Resorbable Bead KitMQV · Traditional | 08/01/2005SE |
| K033046 | Subtalar Peg ImplantMJW · Traditional | 12/23/2003SE |
Questions and answers
When was Classic Great Toe Implant cleared by the FDA?
Classic Great Toe Implant (K023086) received a 510(k) decision of Substantially Equivalent on October 4, 2002, 17 days after the submission was received.
What is the product code of K023086?
The FDA product code is KWH – Prosthesis, Toe, Constrained, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3720.