Product code HXA— Orthopedic
AVANTA ORTHOPAEDICS TENDON SPACER
- Classification name
- Prosthesis, Tendon, Passive
- Device class
- Class 2
- Regulation
- 21 CFR 888.3025
- Advisory panel
- Orthopedic
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code HXA
FDA has cleared devices under product code HXA between 1978 and 2025, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2000
- 1997
- 1993
- 1987
- 1985
- 1978
Top applicants under product code HXA
Recent clearances under product code HXA
- K243477 — Universal Tendon Spacer
- K000019 — SINGLE SIZE TENDON SPACER
- K973385 — OVAL SHAPES
- K964359 — AVANTA ORTHOPAEDICS TENDON SPACER
- K930125 — PHOENIX BONE SCREWS PBS-TYPE SERIES
- K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC
- K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC
- K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC
- K853438 — H-H HUNTER ACTIVE TENDON IMPLANT
- K781943 — TENDON ROD MODEL OR41PO3-6
- K780320 — PASSIVE TENDON IMPLANT
Data sourced from openFDA. This site is unofficial and independent of the FDA.