Subtalar Peg Implant
FDA 510(k) K033046 · Nexa Orthopedics, Inc.
510(k) numberK033046
Submission
- Device name
- Subtalar Peg Implant
- Applicant
- Nexa Orthopedics, Inc.
Vista, CA, US - Received
- September 29, 2003
- Decision date
- December 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJW – Prosthesis, Subtalar, Plug, Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MJW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K922292 | Lundeen Subtalar Peg ImplantMJW · Traditional | Sgarlato Laboratories, Inc. | 10/23/1992SE |
More from Sgarlato Laboratories, 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 |
| K032902 | Subtalar Arthrorisis ImplantHWC · Traditional | 12/15/2003SE |
Questions and answers
When was Subtalar Peg Implant cleared by the FDA?
Subtalar Peg Implant (K033046) received a 510(k) decision of Substantially Equivalent on December 23, 2003, 85 days after the submission was received.
What is the product code of K033046?
The FDA product code is MJW – Prosthesis, Subtalar, Plug, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3040.