510(k) K884561
- Device
- KOENIG TOTAL TOE IMPLANT
- Applicant
- DOW CORNING WRIGHT
- 510(k) number
- K884561
- Product code
- LZJ
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1989-01-24
- Date received
- 1988-10-31
- Regulation
- 510(k) Premarket Notification
- Classification name
- Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Orthopedic
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BAILEY LIPSCOMB
- Address
- P.O. Box 100 Arlington TN US 38002 38002
FDA Registration Numbers#
- 3004154314
- 2027754
- 3014207283
- 3003477135
- 2028632
- 3011277306
- 2029275
- 3006017180
- 1649518
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132496 | ARTHROSURFACE TOEMOTION | Arthrosurface, Inc. | 2014-02-26 |
| K102549 | THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY | Ascension Orthopedics, Inc. | 2010-12-21 |
| K072251 | MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM | Merete Medical GmbH | 2008-05-08 |
| K950864 | GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) | Acu Med, Inc. | 1995-07-31 |
| K941650 | TOTAL TOE SYSTEM II | Biomet, Inc. | 1994-12-19 |
| K924724 | KINETIK GREAT TOE SYSTEM | Kinetikos Medical, Inc. | 1994-01-05 |
| K922211 | OSTEOMED GREAT TOE SYSTEM | Osteomed Corp. | 1993-11-09 |
| K920446 | TOTAL TOE SYSTEM | Biomet, Inc. | 1993-03-22 |
| K920667 | GREAT TOE IMPLANT | Acu Med, Inc. | 1992-06-19 |
| K911552 | ANATOMIC TOE SYSTEM | Orthopaedic Biosystems | 1991-06-28 |
Legacy Summary#
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FDA Review#
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