510(k) K053339
- Device
- ALLOFIX ANCHOR
- Applicant
- MUSCULOSKELETAL TRANSPLANT FOUNDATION
- 510(k) number
- K053339
- Product code
- GAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-03-16
- Date received
- 2005-12-01
- 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
- NANCY L BENNEWITZ
- Address
- 125 May St. Edison NJ US 08837 08837
FDA Registration Numbers#
- 3005064037
- 3012818475
- 9616088
- 3013668043
- 3018094310
- 3008868758
- 3013298431
- 1718850
- 3005953126
- 1062741
- 3002579136
- 3020954746
- 3009018440
- 3021008900
- 3014479313
- 3007319107
- 3004192065
- 3016926753
- 3014276972
- 3008837339
- 1000484830
- 9611459
- 3005381997
- 3022472578
- 3019807891
- 3005180920
- 2244478
- 3006630150
- 3006946276
- 3013302242
- 3010060157
- 3013767421
- 1061124
- 3016727307
- 3006425876
- 2521877
- 2530154
- 3006108336
- 2090040
- 1055236
- 3006981798
- 3021632375
- 3020983460
- 3003139373
- 3008483449
- 3010864832
- 1526012
- 3008114965
- 3003477135
- 3004111573
- 3015806723
- 2030598
- 3011137372
- 3043226252
- 3033509898
- 3004060107
- 3006017180
- 3012329552
- 1066741
- 2936485
- 2246552
- 3008812241
- 3010400367
- 3021226419
- 3010667733
- 3015924373
- 9680794
- 3010146686
- 3021336182
- 1320894
- 2523676
- 3011230048
- 3024021261
- 3015183635
- 3011989923
- 3009732568
- 2031093
- 2648666
- 9612501
- 3010131137
Source Documents#
Other 510(k) Records For Product Code GAT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | 2026-08-22 |
| K261021 | EasyWhip Family | Winter Innovations, Inc. | 2026-07-01 |
| 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 |
Legacy Summary#
summary
FDA Review#
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