510(k) K153087
- Device
- IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved
- Applicant
- Ivy Sports Medicine, LLC
- 510(k) number
- K153087
- Product code
- GAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-07-14
- Date received
- 2015-10-26
- 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
- John Dichiara
- Address
- 545 Penobscot Dr. Redwood City CA US 94063 94063
FDA Registration Numbers#
- 3038718579
- 1221051
- 3003639970
- 2245304
- 3027454646
- 3008812241
- 3030655570
- 3004215117
- 9680794
- 8044102
- 3010146686
- 3014004349
- 2011171
- 1061124
- 1219602
- 3008483449
- 3020899789
- 3011230048
- 3009018440
- 3010041511
- 3017499940
- 2320767
- 3003477135
- 3004944585
- 3008868758
- 3010162973
- 3001592626
- 3007420745
- 3015924373
- 3010131137
- 9612501
- 3015173212
- 3022518322
- 3004111573
- 3010060157
- 3015453963
- 1054811
- 2030624
- 3003267729
- 3006524618
- 3016926753
- 3027339877
- 3007319107
- 2249062
- 3010163695
- 1221934
- 2648666
- 9611459
- 2320762
- 1054241
- 3009672666
- 2124215
- 3006630150
- 3006638824
- 1064584
- 3027605742
- 3029901632
- 3013668043
- 3000215346
- 3017102971
- 3016851379
- 1718850
- 3004117249
- 1450662
- 1226146
- 3013187142
- 2031093
- 3005160949
- 3021008900
- 3010667733
- 3013176080
- 3002807315
- 2030598
- 1062741
- 3002907620
- 3014615644
- 3004549189
- 3027242374
- 3043226252
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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