510(k) K122374
- Device
- ARTHREX SUTURE (UHMWPE)
- Applicant
- ARTHREX, INC.
- 510(k) number
- K122374
- Product code
- GAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-09-25
- Date received
- 2012-08-06
- Regulation
- 878.5000
- Classification name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- IVETTE GALMEZ
- Address
- 1370 Creekside Blvd. Naples FL US 34108 34108
FDA Registration Numbers#
- 3024021261
- 3015173212
- 3014262693
- 3004549189
- 1423537
- 3022472578
- 2024311
- 3017499940
- 3006425876
- 2249062
- 2029275
- 3005064037
- 1000484830
- 2528981
- 3006981798
- 3015330532
- 3008650117
- 2244478
- 3013756169
- 3008812241
- 3021008900
- 3009532798
- 3015974593
- 9610622
- 3003639970
- 3013700547
- 3016851379
- 3007663067
- 3019269298
- 2320767
- 3033509898
- 2648623
- 1000307092
- 3010400367
- 3008110533
- 3010047454
- 3017196117
- 3014004349
- 2936485
- 3002907620
- 9616088
- 3018094310
- 2011171
- 3012883081
- 3010331645
- 3021190802
- 1048735
- 3020983460
- 3006630150
- 2530154
- 3013668043
- 1054241
- 3008868758
- 3006562124
- 2028632
- 2245304
- 9611459
- 3043620689
- 3004117249
- 3015924373
- 3018052045
- 3012470322
- 1320468
- 3015543569
- 3007791573
- 1018470
- 3011706110
- 3017636737
- 3009756327
- 3012103978
- 3004192065
- 1219930
- 3010146686
- 3022518322
- 3014479313
- 1220477
- 3027339877
- 3015231789
- 3015183635
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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