Oval Shapes
FDA 510(k) K973385 · Technical Products, Inc.
510(k) numberK973385
Submission
- Device name
- Oval Shapes
- Applicant
- Technical Products, Inc.
Decatur, GA, US - Received
- September 8, 1997
- Decision date
- December 5, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| K243477 | Universal Tendon SpacerHXA · Traditional | Askorn Medical | 01/10/2025SE |
| K000019 | Single Size Tendon SpacerHXA · Traditional | Medist International | 03/29/2000SE |
| K964359 | Avanta Orthopaedics Tendon SpacerHXA · Traditional | Avanta Orthopaedics, Inc. | 03/25/1997SE |
| 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 |
|---|---|---|
| K013321 | Silicone Tracheal T-TubesBTR · Traditional | 06/04/2002SE |
| K973166 | Dow Corning Silastic Elastomer Q7-4750MIB · Traditional | 11/21/1997SE |
| K971472 | Sil-Tec Nonreinforced Sheeting, Reinforced Sheeting, Radiopaque Sheeting, Reinforced…FTL · Traditional | 07/01/1997SE |
| K971613 | Sil-Tec Small/Large Bore Tubing/Sil-Tec High Durometer Tubing/Sil-Tec Radiopaque TubingMIB · Traditional | 05/22/1997SE |
| K954116 | Silicone Malecot Catheter with Pezzer/Mushroom TipFEW · Traditional | 11/06/1995SE |
Questions and answers
When was Oval Shapes cleared by the FDA?
Oval Shapes (K973385) received a 510(k) decision of Substantially Equivalent on December 5, 1997, 88 days after the submission was received.
What is the product code of K973385?
The FDA product code is HXA – Prosthesis, Tendon, Passive, a Class II (moderate risk) device regulated under 21 CFR 888.3025.