The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium.
| Device ID | K061384 |
| 510k Number | K061384 |
| Device Name: | LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM |
| Classification | Plate, Fixation, Bone |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Kim Reed |
| Correspondent | Kim Reed WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-18 |
| Decision Date | 2006-06-06 |
| Summary: | summary |