FDA product code LZN: Cement Obturator
LZN is the FDA product code for cement obturator. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Orthopedic panel. FDA has cleared 37 510(k) submissions under LZN, 1 in the last five years, from 28 different applicants. The average 510(k) review took 121 days (median 72). FDA has posted 8 recalls for LZN devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cement Obturator |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | OR — Orthopedic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for LZN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 59 |
Compare with all 510(k) review times · Search every LZN clearance
Top LZN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Corp. | 5 | 1995-05-16 |
| Isotis NV | 2 | 2001-04-20 |
| Sunmed, Inc. | 2 | 1996-02-27 |
| Johnson & Johnson Professionals, Inc. | 2 | 1995-05-16 |
| American Design Group, Inc. | 2 | 1991-09-04 |
23 more applicants have LZN clearances. See the full list in Caduvo.
Most recent LZN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220838 | Howmedica Osteonics, Dba Stryker Orthopaedics | Artisan Bone Plug, Universal Cement Restrictor | 2022-05-20 | 59 |
| K061824 | Tornier | TORNIER CEMENT RESTRICTOR | 2006-09-14 | 78 |
| K032685 | Teknimed, S.A. | CEMSTOP CEMENT RESTRICTOR | 2003-11-26 | 89 |
| K023680 | Smith & Nephew, Inc. | BIOBUCK CEMENT RESTRICTOR | 2002-11-19 | 18 |
| K011943 | Kensey Nash Corp. | IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR | 2001-09-19 | 90 |
Recalls for LZN devices
8 product recalls in 2 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2023-08-07.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 7 |
Frequently asked questions
What is FDA product code LZN?
LZN is the FDA product code for cement obturator. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Orthopedic panel.
What device class is LZN?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code LZN?
Across 37 cleared submissions the average was 121 days from receipt to decision (median 72).
Which companies have the most LZN clearances?
Howmedica Corp. (5); Isotis NV (2); Sunmed, Inc. (2); Johnson & Johnson Professionals, Inc. (2); American Design Group, Inc. (2).
Have LZN devices been recalled?
Yes: 8 product recalls across 2 recall events; the most recent began 2023-08-07.
Next steps
- Run an FDA pathway report with predicate devices for product code LZN
- Run a recall and safety report across every LZN manufacturer
- Watch product code LZN 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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