FDA product code HTH: Protractor
HTH is the FDA product code for protractor. It is a Class I device, regulated under 21 CFR 888.4600 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under HTH, from 2 different applicants. The average 510(k) review took 27 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Protractor |
| Device class | Class I |
| Regulation | 21 CFR 888.4600 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HTH clearance
Top HTH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Osteotomy Guide Co. | 2 | 1986-05-12 |
| Frontier Products | 1 | 1982-08-20 |
Most recent HTH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K861576 | Osteotomy Guide Co. | SHORTENING OSTEOTOMY GUIDE | 1986-05-12 | 14 |
| K841470 | Osteotomy Guide Co. | REESE OSTEOTOMY GUIDE SYS | 1984-05-23 | 44 |
| K822305 | Frontier Products | ORTHO-LEVEL | 1982-08-20 | 24 |
Recalls for HTH devices
openFDA lists no recalls for product code HTH.
Frequently asked questions
What is FDA product code HTH?
HTH is the FDA product code for protractor. It is a Class I device, regulated under 21 CFR 888.4600 and reviewed by the Orthopedic panel.
What device class is HTH?
Class I, regulation 21 CFR 888.4600. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTH?
Across 3 cleared submissions the average was 27 days from receipt to decision (median 24).
Which companies have the most HTH clearances?
Osteotomy Guide Co. (2); Frontier Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HTH
- Run a recall and safety report across every HTH manufacturer
- Watch product code HTH 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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