LRNClass II
Wire, Surgical
21 CFR 888.3030 / Orthopedic
LRN is the FDA product code for Wire, Surgical, a class II device type, regulated under 21 CFR 888.3030. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- LRN
- Device name
- Wire, Surgical
- Regulation
- 21 CFR 888.3030
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 8
- Ingested recalls
- 1
Clearances, product code LRN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| 2000 | 1 |
Applicants with the most clearances
Product code LRN| Applicant | Clearances |
|---|---|
| Acu Med, Inc. | 1 |
| Bregma International Trading Company, Ltd. | 1 |
| Danek Medical, Inc. | 1 |
| Howmedica Corp. | 1 |
| Johnson & Johnson Professionals, Inc. | 1 |
| Oxboro Medical Intl., Inc. | 1 |
| T. Korossurgical Instruments Corp. | 1 |
| Winn Hirsch & Assoc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.