Submission Details
| 510(k) Number | K021522 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 10, 2002 |
| Decision Date | May 21, 2002 |
| Days to Decision | 11 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Special
LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW
May 2002
Decision
11d
Days
Class 2
Risk
About This 510(k) Submission
K021522 is an FDA 510(k) clearance for the LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW, a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 21, 2002, 11 days after receiving the submission on May 10, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.
Device Classification
| Product Code | DZL — Screw, Fixation, Intraosseous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4880 |
Manufacturer
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