K090132 is an FDA 510(k) clearance for the MAXMORESPINE SPINAL SYSTEM. This device is classified as a Arthroscope (Class II - Special Controls, product code HRX).
Submitted by Hoogland Spine Products, GmbH (Muenchen, DE). The FDA issued a Cleared decision on June 9, 2009, 139 days after receiving the submission on January 21, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.1100. Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K090132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2009 |
| Decision Date | June 09, 2009 |
| Days to Decision | 139 days |
| Submission Type | Abbreviated |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRX - Arthroscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.1100 |
| Definition | Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |