FDA product code LYQ: Accessories, Fixation, Spinal Intervertebral Body
LYQ is the FDA product code for accessories, fixation, spinal intervertebral body. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under LYQ, from 3 different applicants. The average 510(k) review took 107 days (median 74). FDA has posted 2 recalls for LYQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Fixation, Spinal Intervertebral Body |
| 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 LYQ clearance
Top LYQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ruggles Corp. | 1 | 1989-06-07 |
| Warsaw Orthopedic, Inc. | 1 | 1989-04-06 |
| Terray Manufacturing, Inc. | 1 | 1988-09-23 |
Most recent LYQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893415 | Ruggles Corp. | TRANS-ORAL DEPTH GAUGE | 1989-06-07 | 36 |
| K883784 | Warsaw Orthopedic, Inc. | TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE | 1989-04-06 | 212 |
| K882871 | Terray Manufacturing, Inc. | CASF DRILL GUIDE DG 170 | 1988-09-23 | 74 |
Recalls for LYQ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-05-10.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code LYQ?
LYQ is the FDA product code for accessories, fixation, spinal intervertebral body. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is LYQ?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LYQ?
Across 3 cleared submissions the average was 107 days from receipt to decision (median 74).
Which companies have the most LYQ clearances?
Ruggles Corp. (1); Warsaw Orthopedic, Inc. (1); Terray Manufacturing, Inc. (1).
Have LYQ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-05-10.
Next steps
- Run an FDA pathway report with predicate devices for product code LYQ
- Run a recall and safety report across every LYQ manufacturer
- Watch product code LYQ 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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