510(k) K031188
- Device
- ORTHOMEND
- Applicant
- TEI BIOSCIENCES INC.
- 510(k) number
- K031188
- Product code
- FTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-06-27
- Date received
- 2003-04-15
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Polymeric
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH JAMES
- Address
- 7 Elkins St. Boston MA US 02127 02127
FDA Registration Numbers#
- 3033273526
- 3021194552
- 3002807523
- 9616088
- 3018094310
- 3005953126
- 3014479313
- 3035387162
- 3032412536
- 3026560514
- 3007156625
- 3002806603
- 3016248634
- 3009514842
- 1061124
- 2530154
- 3015860534
- 3010513348
- 3021632375
- 3020983460
- 1614993
- 3030412764
- 3004111573
- 3008812560
- 3002807310
- 8020712
- 3024021261
- 3011989923
- 2031093
- 3010131137
- 3016678045
- 1417592
- 3019101334
- 1017294
- 1018470
- 9617465
- 1835959
- 3007663067
- 3030733800
- 2435947
- 2031966
- 2024024
- 3010178296
- 1058584
- 3009420598
- 3010187263
- 8043734
- 3009756327
- 3039256597
- 3002807315
- 3033302333
- 2024311
- 9615742
- 3027616027
- 3010034780
- 3010673515
- 2132588
- 3017492634
- 2028924
- 3014272734
- 1319639
- 3010237768
- 2022435
- 3011689956
- 3005619880
- 1018233
- 1064584
- 3007321028
- 3002294946
- 3009976880
- 1721676
- 1225687
- 9616062
- 1526534
- 1222928
- 8044102
- 1048735
- 1061771
- 2124215
- 3010383847
Source Documents#
Other 510(k) Records For Product Code FTL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260474 | Liora Monofilament Scaffold | TELA Bio, Inc. | 2026-09-28 |
| K253956 | ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | Sofradim Production | 2026-05-21 |
| K253125 | Parietene™ Flat Sheet Mesh | Medtronic - Sofradim Production | 2025-10-24 |
| K251955 | Onflex™ Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2025-07-24 |
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | Davol, Inc. | 2025-06-12 |
| K250869 | Parietene™ Macroporous Mesh (PPM5050 ) | Sofradim Production | 2025-04-23 |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Davol, Inc. | 2025-04-09 |
| K243315 | ProGrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2025-01-17 |
| K241250 | 3DMax Light Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2024-06-14 |
| K232373 | Progrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2024-01-18 |
| K233402 | Bard 3DMax Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2023-11-01 |
| K232924 | T-Line® Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023-10-18 |
| K230671 | Pitch PaSoft Tissue Reinforcement Device | Xiros, Ltd. | 2023-05-31 |
| K230227 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023-02-23 |
| K223218 | Parietene Macroporous Mesh | Sofradim Production | 2022-12-02 |
Legacy Summary#
summary
FDA Review#
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