FDA product code HXY: Brace, Drill
HXY is the FDA product code for brace, drill. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 7 510(k) submissions under HXY, from 6 different applicants. The average 510(k) review took 64 days (median 48). FDA has posted 1 recall for HXY devices.
Classification
| Field | Value |
|---|---|
| Device name | Brace, Drill |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HXY clearance
Top HXY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthopedic Systems, Inc. | 2 | 1988-03-23 |
| Neimark Labs, Inc. | 1 | 1992-11-06 |
| Mitek Surgical Products, Inc. | 1 | 1989-09-28 |
| Austin Assoc. | 1 | 1988-03-15 |
| Buckman Co., Inc. | 1 | 1988-02-16 |
1 more applicants have HXY clearances. See the full list in Caduvo.
Most recent HXY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923776 | Neimark Labs, Inc. | BENDEREV DRILL GUIDE | 1992-11-06 | 101 |
| K892904 | Mitek Surgical Products, Inc. | MITEK DRILL GUIDE | 1989-09-28 | 161 |
| K880264 | Orthopedic Systems, Inc. | BONE SUTURE FIXATION DEVICE | 1988-03-23 | 61 |
| K880381 | Austin Assoc. | TELOS DISTAL TARGETING DEVICE | 1988-03-15 | 48 |
| K880046 | Buckman Co., Inc. | HASTING FINGER FIXATOR INSTRUMENTS | 1988-02-16 | 41 |
Recalls for HXY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-05-27.
Frequently asked questions
What is FDA product code HXY?
HXY is the FDA product code for brace, drill. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXY?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXY?
Across 7 cleared submissions the average was 64 days from receipt to decision (median 48).
Which companies have the most HXY clearances?
Orthopedic Systems, Inc. (2); Neimark Labs, Inc. (1); Mitek Surgical Products, Inc. (1); Austin Assoc. (1); Buckman Co., Inc. (1).
Have HXY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-05-27.
Next steps
- Run an FDA pathway report with predicate devices for product code HXY
- Run a recall and safety report across every HXY manufacturer
- Watch product code HXY 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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