FDA product code HXR: Spatula, Orthopedic
HXR is the FDA product code for spatula, orthopedic. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under HXR, from 4 different applicants. The average 510(k) review took 122 days (median 136).
Classification
| Field | Value |
|---|---|
| Device name | Spatula, Orthopedic |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HXR clearance
Top HXR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro-Medical Devices, Inc. | 1 | 1999-03-15 |
| Arthropedics, Inc. | 1 | 1987-11-25 |
| Cedar Surgical, Inc. | 1 | 1987-11-02 |
| Holter-Hausner Intl. | 1 | 1985-10-16 |
Most recent HXR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K983882 | Micro-Medical Devices, Inc. | MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 | 1999-03-15 | 133 |
| K873387 | Arthropedics, Inc. | VIDEO ARTHROSCOPE, 1.7MM X 55 MM | 1987-11-25 | 152 |
| K872281 | Cedar Surgical, Inc. | RAYLOR FUSION FUNNEL | 1987-11-02 | 139 |
| K853436 | Holter-Hausner Intl. | H-H HUNTER PASSIVE TENDON IMPLANT | 1985-10-16 | 62 |
Recalls for HXR devices
openFDA lists no recalls for product code HXR.
Frequently asked questions
What is FDA product code HXR?
HXR is the FDA product code for spatula, orthopedic. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is HXR?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXR?
Across 4 cleared submissions the average was 122 days from receipt to decision (median 136).
Which companies have the most HXR clearances?
Micro-Medical Devices, Inc. (1); Arthropedics, Inc. (1); Cedar Surgical, Inc. (1); Holter-Hausner Intl. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HXR
- Run a recall and safety report across every HXR manufacturer
- Watch product code HXR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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