H-H Hunter Active Tendon Implant PC
FDA 510(k) K872284 · Holter-Hausner Intl.
510(k) numberK872284
Submission
- Device name
- H-H Hunter Active Tendon Implant PC
- Applicant
- Holter-Hausner Intl.
Bridgeport, PA, US - Received
- June 16, 1987
- Decision date
- September 28, 1987
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
| 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 |
| 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 |
|---|---|---|
| K875287 | H-H Flushing ReservoirJXG · Traditional | 07/14/1988SE |
| K874508 | H-H External Ventricular Drainage Collection BagJXG · Traditional | 01/19/1988SE |
| K872293 | H-H Hunter Active Tendon Implant BCHXA · Traditional | 09/28/1987SN |
| K872285 | H-H Hunter Active Tendon Implant DCHXA · Traditional | 09/28/1987SN |
| K871351 | H-H Harris Neonatal Nasal Cannula Set for CPAPBZD · Traditional | 05/14/1987SE |
| K870660 | H-H External Ventricular Drain (Evd) Comp./SystemsJXG · Traditional | 05/01/1987SE |
| K865075 | H-H Subgaleal TrocarGYK · Traditional | 01/13/1987SE |
| K853437 | H-H Hunter Tendon Rod · Traditional | 10/16/1985SE |
| K853436 | H-H Hunter Passive Tendon ImplantHXR · Traditional | 10/16/1985SE |
| K853438 | H-H Hunter Active Tendon ImplantHXA · Traditional | 09/30/1985SN |
Questions and answers
When was H-H Hunter Active Tendon Implant PC cleared by the FDA?
H-H Hunter Active Tendon Implant PC (K872284) received a 510(k) decision of Substantially Equivalent for Some Indications on September 28, 1987, 104 days after the submission was received.
What is the product code of K872284?
The FDA product code is HXA – Prosthesis, Tendon, Passive, a Class II (moderate risk) device regulated under 21 CFR 888.3025.