The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Sternal Closure System With Modular Screw.
| Device ID | K011076 |
| 510k Number | K011076 |
| Device Name: | LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-09 |
| Decision Date | 2001-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036147341 | K011076 | 000 |
| 00841036135645 | K011076 | 000 |
| 00841036123857 | K011076 | 000 |
| 00841036123444 | K011076 | 000 |
| 00841036123109 | K011076 | 000 |
| 00841036072544 | K011076 | 000 |
| 00841036070489 | K011076 | 000 |
| 00841036068752 | K011076 | 000 |
| 00841036067809 | K011076 | 000 |
| 00841036135997 | K011076 | 000 |
| 00841036138424 | K011076 | 000 |
| 00841036138462 | K011076 | 000 |
| 00841036143589 | K011076 | 000 |
| 00841036141066 | K011076 | 000 |
| 00841036141059 | K011076 | 000 |
| 00841036141042 | K011076 | 000 |
| 00841036141035 | K011076 | 000 |
| 00841036141028 | K011076 | 000 |
| 00841036141011 | K011076 | 000 |
| 00841036141004 | K011076 | 000 |
| 00841036067045 | K011076 | 000 |