The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Sled Unicompartment Knee System.
| Device ID | K954186 |
| 510k Number | K954186 |
| Device Name: | SLED UNICOMPARTMENT KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | LINK AMERICA, INC. C/O SURGICAL IMPLANTS, INC. 10 GREAT MEADOW LANE East Hanavor, NJ 07936 |
| Contact | Douglas Stuart |
| Correspondent | Douglas Stuart LINK AMERICA, INC. C/O SURGICAL IMPLANTS, INC. 10 GREAT MEADOW LANE East Hanavor, NJ 07936 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-06 |
| Decision Date | 1996-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575436729 | K954186 | 000 |
| 04026575044047 | K954186 | 000 |
| 04026575044030 | K954186 | 000 |
| 04026575044023 | K954186 | 000 |
| 04026575044016 | K954186 | 000 |
| 04026575044009 | K954186 | 000 |
| 04026575043996 | K954186 | 000 |
| 04026575043989 | K954186 | 000 |
| 04026575043972 | K954186 | 000 |
| 04026575043965 | K954186 | 000 |
| 04026575043958 | K954186 | 000 |
| 04026575043941 | K954186 | 000 |
| 04026575043934 | K954186 | 000 |
| 04026575043910 | K954186 | 000 |
| 04026575043903 | K954186 | 000 |
| 04026575044061 | K954186 | 000 |
| 04026575044078 | K954186 | 000 |
| 04026575436712 | K954186 | 000 |
| 04026575436705 | K954186 | 000 |
| 04026575359486 | K954186 | 000 |
| 04026575359479 | K954186 | 000 |
| 04026575359462 | K954186 | 000 |
| 04026575359455 | K954186 | 000 |
| 04026575209491 | K954186 | 000 |
| 04026575044160 | K954186 | 000 |
| 04026575044153 | K954186 | 000 |
| 04026575044146 | K954186 | 000 |
| 04026575044122 | K954186 | 000 |
| 04026575044115 | K954186 | 000 |
| 04026575044108 | K954186 | 000 |
| 04026575044085 | K954186 | 000 |
| 04026575043897 | K954186 | 000 |