510(k) K222097
- Device
- OLYMPIC Deformity Band System
- Applicant
- Astura Medical
- 510(k) number
- K222097
- Product code
- OWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-04
- Date received
- 2022-07-18
- Regulation
- 888.3010
- Classification name
- Bone Fixation Cerclage, Sublaminar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Parker Kelch
- Address
- 4949 W. Royal Ln. Irving TX US 75063 75063
FDA Registration Numbers
- 3016050940
- 3006217744
- 9611390
- 3003477135
- 3003120897
- 3009756327
- 1835251
- 3004893332
- 3006639944
- 1000517406
- 3010370880
- 3009973699
- 3005497913
- 1722511
- 3010120339
- 3014252644
- 3006563559
- 3016438694
- 1720929
- 3009973336
- 3010041430
- 3043543260
- 2027467
- 3006128100
- 3015941638
- 3006791286
- 3019878714
- 3009973505
- 3003935342
- 3013055499
- 3005706667
- 1030489
- 3010462278
- 1833920
- 3012447612
- 3030412764
- 1221763
- 9616062
- 3004142400
- 3011221483
- 2031966
- 3010120135
- 3013378907
- 3007353762
- 3009144915
- 3004024955
- 1643817
- 3010032903
- 3009380063
- 3004774118
- 3003761012
- 3006460162
- 3004638532
- 3012120772
- 1836357
- 1526534
- 3010123206
- 1527105
- 3018094310
- 3010162973
- 3009959868
- 1000432246
- 1226544
- 3006846753
- 3007675554
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00840085250873 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085243783 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085250248 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085250255 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085250262 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085250279 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085250842 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085250859 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085250866 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085261268 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085250880 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085250897 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085250903 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085250910 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085252778 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085253447 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
| 00840085253454 | NA | HYHTE HOLDINGS, INC. | 2023-05-15 |
Other 510(k) Records For Product Code OWI
| 510(k) | Device | Applicant | Decision date |
|---|
| K253615 | Invictus Bands System | Alphatec Spine, Inc. | 2026-03-25 |
| K230565 | HILINE Fixation System | Globus Medical, Inc. | 2023-04-20 |
| K213659 | LigaPASS 2.0 Ligament Augmentation System | Medicrea International SA | 2022-05-24 |
| K211057 | LigaPASS® Spinal System, CD Horizon Spinal System | Medtronic, Inc. | 2021-05-27 |
| K201240 | Mariner Cap System | SeaSpine Orthopedics Corporation | 2020-08-05 |
| K200281 | The Gecko Spinal System | Ortho Development Corporation | 2020-03-31 |
| K200097 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | 2020-03-16 |
| K191217 | JAZZ PF | Implanet, S.A. | 2019-08-02 |
| K190289 | Karma® Fixation System | Spinal Elements, Inc. | 2019-04-03 |
| K190418 | NuVasive® VersaTie® System | Nu Vasive, Incorporated | 2019-03-21 |
| K180728 | Spinal Elements Cerclage System | Spinal Elements, Inc. | 2018-09-06 |
| K181799 | ResCUBE Ligament Fixation System | Cousin Biotech Sas | 2018-08-29 |
| K172206 | NAJA Ligament Correction System | Cousin Biotech Sas | 2018-04-10 |
| K173506 | LigaPASS | Medicrea International SA | 2018-04-03 |
| K173117 | NuVasive® VersaTie System | Nuvasive, Inc. | 2017-12-07 |