510(k) K002083 ยท JEY Plate, Bone
LORENZ RESORBABLE DISTRACTOR SYSTEM
| Applicant | Walter Lorenz Surgical, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Feb 12, 2001 |
| Received | Jul 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002083
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Walter Lorenz Surgical, Inc. Product is 40mm Flexible Tube. ***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN."
W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 T Terminated |
JEY | None listed |
| Jan 11, 2012 | Walter Lorenz Surgical, Inc. Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN."
W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRAD Terminated |
JEY | None listed |
| Jan 11, 2012 | Walter Lorenz Surgical, Inc. Product is 35mm Flex Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN."
W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRADEPOR Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.