Device class
Class II
Regulation 888.3030
Total clearances
3
2022-01-21 → 2024-08-28
Classification details
Medical specialty
Orthopedic
Regulation number
888.3030
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
OSSIO , Ltd.
|
3 |
0 |
2024-08-28 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 20694 |
CPT
|
— |
Medium
|
Removal of hardware not elsewhere specified |
| A4611 |
HCPCS
|
Battery, heavy duty; replacement for patient owned ventilator ✓ CMS-verified description |
Medium
|
Staple/clamp application device with clamps; per application (orthopedic absorbable staple) |
Pulse
Most recent 510(k) clearances