This page includes the latest FDA filings for Isimac Machine Co Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3007925235 |
| FEI Number | 3007925235 |
| Name | ISIMAC MACHINE CO INC. |
| Owner & Operator | Isimac Machine Co Inc. |
| Contact Address | 321 June Ave Blandon PA 19510 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 321 June Ave Blandon, PA 19510 US |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
Device Company | Device | Date |
|---|---|---|
ISIMAC MACHINE CO INC. | Synthes(USA) Synthes Hybrid External Fixator (393.721, 393.722, 393.731, 393.732, 393.734, 393.735, 393.736, 393.737) | 2017-08-22 |
ISIMAC MACHINE CO INC. | Synthes Small External Fixation System Synthes Large External Fixation System (390.006, 390.011, 390.012, 390.013) | 2017-08-22 |
ISIMAC MACHINE CO INC. | Synthes Navigable Pedicle Preperation Instruments (03.632.230, 03.632.422) | 2017-08-22 |
ISIMAC MACHINE CO INC. | Synthes External Fixation Devices Mr Conditional (390.028, 390.029, 390.030, 390.032) | 2017-08-22 |
ISIMAC MACHINE CO INC. | Synthes Large External Fixation Mr Conditional (390.006, 390.011, 390.012, 390.013,) | 2017-08-22 |
ISIMAC MACHINE CO INC. | Synthes(USA) Curvilinear Distraction System (04.500.018, 04.500.100, 04.500.130, 04.500.140, 04.500.150, 04.500.170) | 2017-08-22 |
ISIMAC MACHINE CO INC. | Synthes (USA) External Fixation Component Line Extension-Mr Safe (390.011, 390.012, 390.013, 390.028, 390.029, 390.030) | 2017-08-22 |
ISIMAC MACHINE CO INC. | Synthes Medium External Fixation System-Mr Safe (390.032) | 2017-08-21 |
ISIMAC MACHINE CO INC. | SYNTHES EXTERNAL MIDFACE DISTRACTOR (390.100) (390.102) (390.104) (390.106) (390.108) | 2017-08-21 |
ISIMAC MACHINE CO INC. | Synthes Reprocessed External Fixation Devices (393.721, 393.722, 393.731, 393.732, 393.734, 393.735, 393.736, 393.737) | 2017-08-21 |
ISIMAC MACHINE CO INC. | SYNTHESLARGE COMBINATIONCLAMP DYNAMIZATION CLIP-MR SAFE (390.106) | 2017-08-21 |
ISIMAC MACHINE CO INC. | Orthopedic Manual Surgical Instrument (03.010.113, 03.315.004, 03.809.732, 355.016, 357.377, 357.378, 357.396,.357.397) | 2017-08-21 |
ISIMAC MACHINE CO INC. | Screwdriver (03.614.039) | 2017-08-21 |
ISIMAC MACHINE CO INC. | Mallet (03.010.059) | 2017-08-21 |
ISIMAC MACHINE CO INC. | Wrench (388.262) | 2017-08-21 |
ISIMAC MACHINE CO INC. | Rasp (03.809.819, 03.809.821, 03.809.823, 03.809.825, 03.809.827) | 2017-08-21 |
ISIMAC MACHINE CO INC. | Gauge, Depth (351.719) | 2017-08-21 |
ISIMAC MACHINE CO INC. | Forceps (03.632.205, 03.632.210) | 2017-08-21 |
ISIMAC MACHINE CO INC. | Apparatus, traction, non-powered (357.371) | 2017-08-21 |
ISIMAC MACHINE CO INC. | RETRACTOR (03.809.903 ,03.809.904, 03.809.905, 03.809.906, 03.809.907, 03.809.908, 03.809.909, 03.809.910, 03.809.911) | 2017-08-21 |
ISIMAC MACHINE CO INC. | GUIDE, SURGICAL, INSTRUMENT (03.100.140, 03.100.141, 03.100.142, 03.641.014, 04.500.616, 312.156, 338.047, 357.397) | 2017-08-21 |
| NCAGE Code | 3D721 | ISIMAC MACHINE CO INC |
| NCAGE Code | 50078 | ISIMAC MACHINE COMPANY INC. |
| NCAGE Code | 9D955 | ISIMAC MACHINE CO INC |
| CAGE Code | 50078 | ISIMAC MACHINE COMPANY, INC. |
| CAGE Code | 3D721 | ISIMAC MACHINE CO INC |
| CAGE Code | 9D955 | ISIMAC MACHINE CO INC |
| DUNS | 002515195 | ISIMAC MACHINE COMPANY, INC. |