The following data is part of a premarket notification filed by Stryker Spine with the FDA for Navigated Spine Instruments.
| Device ID | K203205 |
| 510k Number | K203205 |
| Device Name: | Navigated Spine Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Stryker Spine 600 Hope Parkway SE Leesburg, VA 20175 |
| Contact | Megan Callanan |
| Correspondent | Megan Callanan Stryker Spine 600 Hope Parkway SE Leesburg, VA 20175 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-30 |
| Decision Date | 2021-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857549364 | K203205 | 000 |
| 10888857480902 | K203205 | 000 |
| 10888857480919 | K203205 | 000 |
| 10888857480926 | K203205 | 000 |
| 10888857480933 | K203205 | 000 |
| 10888857480940 | K203205 | 000 |
| 10888857480957 | K203205 | 000 |
| 10888857480964 | K203205 | 000 |
| 10888857480971 | K203205 | 000 |
| 10888857480896 | K203205 | 000 |
| 10888857480889 | K203205 | 000 |
| 10888857480872 | K203205 | 000 |
| 10888857549371 | K203205 | 000 |
| 10888857549388 | K203205 | 000 |
| 10888857549395 | K203205 | 000 |
| 10888857549401 | K203205 | 000 |
| 10888857549418 | K203205 | 000 |
| 10888857480841 | K203205 | 000 |
| 10888857480858 | K203205 | 000 |
| 10888857480865 | K203205 | 000 |
| 10888857480988 | K203205 | 000 |
| 10888857480995 | K203205 | 000 |
| 10888857481114 | K203205 | 000 |
| 10888857481121 | K203205 | 000 |
| 10888857481138 | K203205 | 000 |
| 10888857481145 | K203205 | 000 |
| 10888857488083 | K203205 | 000 |
| 10888857488090 | K203205 | 000 |
| 10888857488106 | K203205 | 000 |
| 10888857514782 | K203205 | 000 |
| 10888857481107 | K203205 | 000 |
| 10888857481091 | K203205 | 000 |
| 10888857481084 | K203205 | 000 |
| 10888857481008 | K203205 | 000 |
| 10888857481015 | K203205 | 000 |
| 10888857481022 | K203205 | 000 |
| 10888857481039 | K203205 | 000 |
| 10888857481046 | K203205 | 000 |
| 10888857481053 | K203205 | 000 |
| 10888857481060 | K203205 | 000 |
| 10888857481077 | K203205 | 000 |
| 10888857514799 | K203205 | 000 |