FDA product code HTZ: Instrument, Cutting, Orthopedic
HTZ is the FDA product code for instrument, cutting, 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 21 510(k) submissions under HTZ, from 11 different applicants. The average 510(k) review took 53 days (median 36). FDA has posted 27 recalls for HTZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Cutting, 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 HTZ clearance
Top HTZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stainless Mfg., Inc. | 9 | 1984-08-15 |
| Synvasive Technology, Inc. | 2 | 1994-04-15 |
| Dentronix, Inc. | 2 | 1977-06-17 |
| Bowen & Company, Inc. | 1 | 1987-03-23 |
| Pilling Co. | 1 | 1985-09-24 |
6 more applicants have HTZ clearances. See the full list in Caduvo.
Most recent HTZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933933 | Synvasive Technology, Inc. | CEBOPLANE | 1994-04-15 | 247 |
| K931737 | Synvasive Technology, Inc. | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH | 1994-01-07 | 275 |
| K870882 | Bowen & Company, Inc. | 45 DEGREE SHAVER | 1987-03-23 | 18 |
| K853678 | Pilling Co. | KAMBIN SPINAL INSTRUMENT SET | 1985-09-24 | 21 |
| K850527 | T. Korossurgical Instruments Corp. | ARTHROSCOPY SUCTION BIOPSY PUNCH | 1985-03-14 | 35 |
Recalls for HTZ devices
27 product recalls in 8 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-01-03.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code HTZ?
HTZ is the FDA product code for instrument, cutting, 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 HTZ?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTZ?
Across 21 cleared submissions the average was 53 days from receipt to decision (median 36).
Which companies have the most HTZ clearances?
Stainless Mfg., Inc. (9); Synvasive Technology, Inc. (2); Dentronix, Inc. (2); Bowen & Company, Inc. (1); Pilling Co. (1).
Have HTZ devices been recalled?
Yes: 27 product recalls across 8 recall events; the most recent began 2020-01-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HTZ
- Run a recall and safety report across every HTZ manufacturer
- Watch product code HTZ 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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