BioSphere Flex
Synergy Biomedical
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010258202 | 3010258202 | SYNERGY BIOMEDICAL | 1 | N | 2026-01-01 | 565 E. Swedesford Rd Suite 310 Wayne PA US 19087 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| M958BMS250KT0 | BioSphere MIS Kit - BMS-250KT | 484-902-8141 | info@synergybiomedical.com |
| M958BMS250RC0 | BioSphere MIS Replacement Cannula - BMS-250RC | 484-902-8141 | info@synergybiomedical.com |
| M958BSF000300 | BioSphere Flex SP Extremities, Small - BSF-00030 | 484-902-8141 | customerservice@synergybiomedical.com |
| M958BSF000400 | BioSphere Flex SP Extremities, Medium - BSF-00040 | 484-902-8141 | customerservice@synergybiomedical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 158723 | 1544037150 | K173424 | BioSphere Flex | MQV | 2018-09-12 |
| 158723 | 1409842717 | K173301 | BioSphere MIS Putty (BioSphere MIS) | MQV | 2018-01-19 |
| 158723 | 1506552930 | K140844 | BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC | MQV | 2014-07-16 |
| 158723 | 1101763242 | K122868 | BIOSPHERE BIOACTIVE BONE GRAFT PUTTY | MQV | 2013-04-19 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MQV | 4 | 2018-09-12 |
Synergy Biomedical
Synergy Biomedical, Llc
SYNERGY BIOMEDICAL, INC.
Synergy Biomedical, LLC
2024-12-09
2024-12-09
2021-06-01
2021-06-01
2021-06-01
2021-06-01
2020-01-31