510(k) K203393
- Device
- FAST-FIX FLEX
- Applicant
- Smith & Nephew, Inc.
- 510(k) number
- K203393
- Product code
- GAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-01
- Date received
- 2020-11-18
- Regulation
- 878.5000
- Classification name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Crystal Morales
- Address
- 7135 Goodlett Farms Pkwy. Cordova TN US 38016 38016
FDA Registration Numbers#
- 3010131137
- 3012421607
- 1221934
- 3014279513
- 9616088
- 3013700547
- 1221601
- 1061124
- 3022518322
- 1045254
- 2183301
- 3010331645
- 3010146686
- 3015806723
- 3006630150
- 3004549189
- 1718850
- 2031093
- 2090040
- 2528981
- 2024311
- 3027242374
- 3007109793
- 2320767
- 3020983460
- 3016904853
- 1721676
- 3013403214
- 3013187142
- 3015974593
- 1064584
- 3003477135
- 3006425876
- 3003639970
- 3011137372
- 2936485
- 1000484830
- 3016678045
- 3002719998
- 3006562124
- 3010452421
- 3012358417
- 1220246
- 3033509898
- 3006524618
- 3021336182
- 3020899789
- 3006946276
- 3006272282
- 3038718579
- 1825034
- 3014461810
- 3008114965
- 3014579161
- 1066741
- 3021632375
- 2011171
- 3014262693
- 3007420745
- 3013298431
- 3016851379
- 1320468
- 3029901632
- 3009732568
- 3008812241
- 3009513193
- 1054811
- 3035366890
- 2028632
- 3004192065
- 3013548553
- 3003267729
- 3011061237
- 3015724777
- 3008793310
- 1220477
- 3017210488
- 2245304
- 3017196117
Source Documents#
Other 510(k) Records For Product Code GAT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ | Teleflex Medical, LLC | 2026-05-06 |
| K254275 | HyperSuture All Green Extension Line | Threadstone, LLC | 2026-03-23 |
| K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | 2026-02-19 |
| K253145 | Pre-Sutured Tendon | Rti Surgical, Inc. | 2025-10-22 |
| K253024 | ProZip Knotless Implant | Riverpoint Medical | 2025-10-16 |
| K252225 | PowerKnot High Strength Sutures | Medacta International S.A. | 2025-09-12 |
| K252201 | HS Fiber | Riverpoint Medical | 2025-08-13 |
| K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025-03-27 |
| K241376 | HyperSuture All Blue Extension Line | Threadstone, LLC | 2024-08-09 |
| K234079 | HyperSuture Extension Line | Threadstone, LLC | 2024-05-10 |
| K231163 | HS Fiber Sutures | Riverpoint Medical | 2024-01-05 |
| K230311 | HyperSuture | Threadstone, LLC | 2023-11-24 |
| K231183 | Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. | 2023-08-25 |
| K223500 | SuperBall Meniscal Repair System | Arcuro Medical , Ltd. | 2023-08-10 |
| K223122 | MENIX®; MENIX® DUO | S.B.M. Sas (Science & Bio Materials) | 2023-08-03 |
Legacy Summary#
summary
FDA Review#
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