The following data is part of a premarket notification filed by Genesis Medical L.l.c. with the FDA for Genesis Total Shoulder Replacement, Model 100-01-00.
| Device ID | K043346 |
| 510k Number | K043346 |
| Device Name: | GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | GENESIS MEDICAL L.L.C. 2650 US HIGHWAY 130 Cranbury, NJ 08512 |
| Contact | Perry Geremakis |
| Correspondent | Perry Geremakis GENESIS MEDICAL L.L.C. 2650 US HIGHWAY 130 Cranbury, NJ 08512 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-06 |
| Decision Date | 2005-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B59910301030 | K043346 | 000 |
| B59910152150 | K043346 | 000 |
| B59910148210 | K043346 | 000 |
| B59910148180 | K043346 | 000 |
| B59910148150 | K043346 | 000 |
| B59910144210 | K043346 | 000 |
| B59910144180 | K043346 | 000 |
| B59910144150 | K043346 | 000 |
| B59910140210 | K043346 | 000 |
| B59910140180 | K043346 | 000 |
| B59910140150 | K043346 | 000 |
| B59910005010 | K043346 | 000 |
| B59910004010 | K043346 | 000 |
| B59910003010 | K043346 | 000 |
| B59910002010 | K043346 | 000 |
| B59910152180 | K043346 | 000 |
| B59910152210 | K043346 | 000 |
| B59910301020 | K043346 | 000 |
| B59910301010 | K043346 | 000 |
| B59910301000 | K043346 | 000 |
| B59910256210 | K043346 | 000 |
| B59910256180 | K043346 | 000 |
| B59910252210 | K043346 | 000 |
| B59910252180 | K043346 | 000 |
| B59910248210 | K043346 | 000 |
| B59910248180 | K043346 | 000 |
| B59910244210 | K043346 | 000 |
| B59910244180 | K043346 | 000 |
| B59910156210 | K043346 | 000 |
| B59910156180 | K043346 | 000 |
| B59910156150 | K043346 | 000 |
| B59910001000 | K043346 | 000 |