The following data is part of a premarket notification filed by Ignite Orthopedics, Inc. with the FDA for Revolution Radial Head.
| Device ID | K183618 |
| 510k Number | K183618 |
| Device Name: | Revolution Radial Head |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | Ignite Orthopedics, Inc. 210 North Buffalo Street Warsaw,, IN 46580 |
| Contact | Russ Parrott |
| Correspondent | Russ Parrott Ignite Orthopedics, Inc. 210 North Buffalo Street Warsaw,, IN 46580 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886982300829 | K183618 | 000 |
| 07612334208019 | K183618 | 000 |
| 07612334208002 | K183618 | 000 |
| 07612334207999 | K183618 | 000 |
| 07612334207982 | K183618 | 000 |
| 07612334207975 | K183618 | 000 |
| 07612334213969 | K183618 | 000 |
| 07612334213952 | K183618 | 000 |
| 07612334213945 | K183618 | 000 |
| 07612334213938 | K183618 | 000 |
| 07612334213921 | K183618 | 000 |
| 07612334213914 | K183618 | 000 |
| 07612334213907 | K183618 | 000 |
| 07612334213891 | K183618 | 000 |
| 07612334208026 | K183618 | 000 |
| 07612334208033 | K183618 | 000 |
| 07612334208040 | K183618 | 000 |
| 07612334213877 | K183618 | 000 |
| 07612334213860 | K183618 | 000 |
| 07612334213853 | K183618 | 000 |
| 07612334213846 | K183618 | 000 |
| 07612334213839 | K183618 | 000 |
| 07612334213822 | K183618 | 000 |
| 07612334213815 | K183618 | 000 |
| 07612334213808 | K183618 | 000 |
| 07612334213792 | K183618 | 000 |
| 07612334213785 | K183618 | 000 |
| 07612334213778 | K183618 | 000 |
| 07612334213761 | K183618 | 000 |
| 07612334213754 | K183618 | 000 |
| 07612334213884 | K183618 | 000 |