Avanta Orthopaedics Tendon Spacer
FDA 510(k) K964359 · Avanta Orthopaedics, Inc.
510(k) numberK964359
Submission
- Device name
- Avanta Orthopaedics Tendon Spacer
- Applicant
- Avanta Orthopaedics, Inc.
San Diego, CA, US - Received
- November 1, 1996
- Decision date
- March 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HXA – Prosthesis, Tendon, Passive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3025
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HXA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243477 | Universal Tendon SpacerHXA · Traditional | Askorn Medical | 01/10/2025SE |
| K000019 | Single Size Tendon SpacerHXA · Traditional | Medist International | 03/29/2000SE |
| K973385 | Oval ShapesHXA · Traditional | Technical Products, Inc. | 12/05/1997SE |
| K930125 | Phoenix Bone Screws Pbs-Type SeriesHXA · Traditional | Phoenix Bioengineering, Inc. | 12/30/1993SE |
| K872293 | H-H Hunter Active Tendon Implant BCHXA · Traditional | Holter-Hausner Intl. | 09/28/1987SN |
| K872285 | H-H Hunter Active Tendon Implant DCHXA · Traditional | Holter-Hausner Intl. | 09/28/1987SN |
| K872284 | H-H Hunter Active Tendon Implant PCHXA · Traditional | Holter-Hausner Intl. | 09/28/1987SN |
| K853438 | H-H Hunter Active Tendon ImplantHXA · Traditional | Holter-Hausner Intl. | 09/30/1985SN |
| K781943 | Tendon Rod Model OR41PO3-6HXA · Traditional | Holter-Hausner Intl. | 12/04/1978SE |
| K780320 | Passive Tendon ImplantHXA · Traditional | Holter-Hausner Intl. | 03/17/1978SE |
More from Holter-Hausner Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K030881 | Avanta Carpal Fusion Plating SystemHRS · Traditional | 04/10/2003SE |
| K021859 | Wrist ImplantJWJ · Traditional | 12/02/2002SE |
| K023604 | Modification to Radial Head ImplantKWI · Special | 11/27/2002SE |
| K013629 | Finger Joint ProsthesisKYJ · Traditional | 01/25/2002SE |
| K011819 | Radial Head ImplantKWI · Special | 06/19/2001SE |
| K010847 | K'FixNDL · Traditional | 06/19/2001SE |
| K003033 | Scaphix, Staple, Fixation, BoneJDR · Traditional | 05/30/2001SE |
| K010786 | Ulnar Head ImplantKXE · Special | 04/11/2001SE |
| K002644 | Radial Head ImplantKWI · Traditional | 11/20/2000SE |
| K990596 | Distal Radius Fracture Fixation Plate SystemHRS · Traditional | 04/29/1999SE |
Questions and answers
When was Avanta Orthopaedics Tendon Spacer cleared by the FDA?
Avanta Orthopaedics Tendon Spacer (K964359) received a 510(k) decision of Substantially Equivalent on March 25, 1997, 144 days after the submission was received.
What is the product code of K964359?
The FDA product code is HXA – Prosthesis, Tendon, Passive, a Class II (moderate risk) device regulated under 21 CFR 888.3025.