510(k) K121606
- Device
- RESORB-X G
- Applicant
- KLS-MARTIN L.P.
- 510(k) number
- K121606
- Product code
- GWO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-01-17
- Date received
- 2012-06-01
- Regulation
- 882.5320
- Classification name
- Plate, Cranioplasty, Preformed, Alterable
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JENNIFER DAMATO
- Address
- 11201 Saint Johns Industrial Pkwy. S Jacksonville FL US 32246 32246
FDA Registration Numbers#
- 1226425
- 3004719693
- 3004464325
- 2027148
- 1032347
- 2029275
- 2027754
- 3011530718
- 1000606483
- 1057946
- 3008812560
- 3003477135
- 3004049923
- 2916714
- 3025141
- 1054811
- 3007738812
- 3009417901
- 1724955
- 8010177
- 3006017180
- 1825034
- 9610905
- 3008791302
- 3015212339
- 1649518
- 3007923096
- 3017884860
- 3009424796
- 2249697
- 2530154
- 3015399803
- 3008868758
- 3034676720
Source Documents#
Other 510(k) Records For Product Code GWO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250297 | TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. | 2025-10-27 |
| K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. | 2025-07-25 |
| K231834 | VSP PEEK Cranial Implant | 3D Systems, Inc. | 2024-04-04 |
| K212391 | MCI-Neuro Fixation System | Mci Medical Concept Innovation, Inc. | 2022-10-21 |
| K210360 | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) | Osteonic Co., Ltd. | 2022-01-27 |
| K203055 | Stryker PEEK Customized Cranial Implant Kit | Stryker | 2021-02-09 |
| K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | 2019-11-27 |
| K190229 | Stryker PEEK Customized Cranial Implant Kit | Stryker | 2019-07-11 |
| K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019-05-21 |
| K183352 | Optimus Neuro System | Osteonic Co., Ltd. | 2019-01-02 |
| K182425 | Universal Mesh - Sterile | Stryker Leibinger GmbH & Co KG | 2018-11-06 |
| K170725 | Stryker Universal Mesh | Stryker | 2017-11-13 |
| K170368 | Sterile NS System | Jeil Medical Corporation | 2017-09-11 |
| K161821 | Stryker Universal Mesh | Stryker | 2016-12-08 |
| K161446 | Biopor Porous Polyethylene Implants | Ceremed , Inc. | 2016-09-27 |
Legacy Summary#
summary
FDA Review#
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