510(k) K210731
- Device
- KLS Martin Individual Patient Solutions
- Applicant
- KLS-Martin L.P.
- 510(k) number
- K210731
- Product code
- JEY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-18
- Date received
- 2021-03-11
- Regulation
- 872.4760
- Classification name
- Plate, Bone
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Jennifer Damato
- Address
- 11201 Saint Johns Industrial Pkwy. S Jacksonville FL US 32246 32246
FDA Registration Numbers
- 3003587896
- 1057946
- 1650372
- 3004464325
- 3009158523
- 1824199
- 2032098
- 3015212339
- 1066741
- 3034676720
- 3013111692
- 9610612
- 3010326886
- 2027754
- 2029005
- 3015882686
- 3017521423
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- 3014483751
- 3009551666
- 2024024
- 3011423165
- 2916714
- 3007923096
- 8010177
- 3005554774
- 8010099
- 1060818
- 3011302692
- 2530154
- 9710629
- 3002862271
- 1649518
- 9681465
- 3005515228
- 3025141
- 1030489
- 3011824442
- 3021635140
- 1057425
- 3002807310
- 2032542
- 3009417901
- 3010287729
- 8031010
- 3000270450
- 3006001176
- 3014937101
- 3015780293
- 1828288
- 3008791302
- 1420032
- 3008812560
- 3009196021
- 1226425
- 1825034
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- 9681851
- 3015531529
- 9610905
- 3009555440
- 3005497913
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- 3015440604
- 3011530718
- 3003236702
- 3015399803
- 3027157194
- 3015869493
- 3009383407
- 3011196443
- 3010155648
- 3003394081
- 8010468
- 9610921
- 3003108161
- 3014128887
- 8043792
- 3010362364
- 3010363503
- 3018094310
- 3003998208
- 3004187715
Source Documents
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| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | 2022-11-09 |
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| K202969 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2021-08-05 |