FDA product code LRN: Wire, Surgical
LRN is the FDA product code for wire, surgical. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 8 510(k) submissions under LRN, from 8 different applicants. The average 510(k) review took 112 days (median 96). FDA has posted 1 recall for LRN devices.
Classification
| Field | Value |
|---|---|
| Device name | Wire, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LRN clearance
Top LRN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| T. Korossurgical Instruments Corp. | 1 | 2000-12-04 |
| Bregma International Trading Company , Ltd. | 1 | 1999-07-08 |
| Johnson & Johnson Professionals, Inc. | 1 | 1997-06-27 |
| Oxboro Medical Intl., Inc. | 1 | 1995-09-15 |
| Acu Med, Inc. | 1 | 1994-11-09 |
3 more applicants have LRN clearances. See the full list in Caduvo.
Most recent LRN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K002755 | T. Korossurgical Instruments Corp. | NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE | 2000-12-04 | 90 |
| K990355 | Bregma International Trading Company , Ltd. | STAINLESS STEEL SOFT SUTURE WIRE | 1999-07-08 | 153 |
| K971682 | Johnson & Johnson Professionals, Inc. | J-FX CERCLAGE SYSTEM | 1997-06-27 | 52 |
| K952783 | Oxboro Medical Intl., Inc. | OXBORO-MEDICAL PIN COVERS | 1995-09-15 | 88 |
| K942603 | Acu Med, Inc. | ORTHOPAEDIC WIRES | 1994-11-09 | 161 |
Recalls for LRN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-09-10.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code LRN?
LRN is the FDA product code for wire, surgical. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is LRN?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code LRN?
Across 8 cleared submissions the average was 112 days from receipt to decision (median 96).
Which companies have the most LRN clearances?
T. Korossurgical Instruments Corp. (1); Bregma International Trading Company , Ltd. (1); Johnson & Johnson Professionals, Inc. (1); Oxboro Medical Intl., Inc. (1); Acu Med, Inc. (1).
Have LRN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-09-10.
Next steps
- Run an FDA pathway report with predicate devices for product code LRN
- Run a recall and safety report across every LRN manufacturer
- Watch product code LRN 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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