FDA product code HSZ: Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
HSZ is the FDA product code for instrument, surgical, orthopedic, pneumatic powered & accessory/attachment. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the Orthopedic panel. FDA has cleared 56 510(k) submissions under HSZ, from 35 different applicants. The average 510(k) review took 87 days (median 49). FDA has posted 6 recalls for HSZ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | OR — Orthopedic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HSZ clearance
Top HSZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro-Aire Surgical Instruments, Inc. | 8 | 1990-11-26 |
| The Anspach Effort, Inc. | 4 | 1996-01-17 |
| Tava Surgical Instruments | 3 | 1994-04-21 |
| Micro Surgical Instruments Corp. | 3 | 1992-02-05 |
| American Sterilizer Co. | 3 | 1980-02-19 |
30 more applicants have HSZ clearances. See the full list in Caduvo.
Most recent HSZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991588 | (Ems Sa) Electro Medical Systems | EMS SWISS ORTHOCLAST | 1999-07-21 | 75 |
| K972860 | Biolectron, Inc. | CURVTEK TSR SYSTEM | 1997-10-31 | 88 |
| K970345 | Richard Wolf Medical Instruments Corp. | ALIGNMENT INSTRUMENT | 1997-04-29 | 90 |
| K955084 | The Anspach Effort, Inc. | ASPACH 65,000 (MODIFICATION) | 1996-01-17 | 90 |
| K954080 | Sodem Diffusion SA | SODEM HIGH SPEED SYSTEM | 1995-10-16 | 46 |
Recalls for HSZ devices
6 product recalls in 5 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-01-24.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code HSZ?
HSZ is the FDA product code for instrument, surgical, orthopedic, pneumatic powered & accessory/attachment. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the Orthopedic panel.
What device class is HSZ?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HSZ?
Across 56 cleared submissions the average was 87 days from receipt to decision (median 49).
Which companies have the most HSZ clearances?
Micro-Aire Surgical Instruments, Inc. (8); The Anspach Effort, Inc. (4); Tava Surgical Instruments (3); Micro Surgical Instruments Corp. (3); American Sterilizer Co. (3).
Have HSZ devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2024-01-24.
Next steps
- Run an FDA pathway report with predicate devices for product code HSZ
- Run a recall and safety report across every HSZ manufacturer
- Watch product code HSZ 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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