Panels › Orthopedic › Product code HTN · Class 2
Washer, Bolt Nut
Regulation 888.3030
3510(k)s in 12 months (93 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in HTN
| Company | 510(k)s | Recalls |
|---|---|---|
| Arthrex, Inc. | 16 | 1 |
| Dallen Medical, Inc. | 5 | 0 |
| Synthes (Usa) | 5 | 0 |
| Acu Med, Inc. | 4 | 0 |
| Acumed, LLC | 4 | 0 |
| Akros Medical | 3 | 0 |
| Buckman Co., Inc. | 3 | 0 |
| Instratek, Inc. | 3 | 0 |
| TriMed, Inc. | 2 | 1 |
| Arthrosurface, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2023 | TriMed Inc. RipCord Syndesmosis Button, REF: STA001K Open, Classified |
HTN | K220650 |
| Oct 10, 2019 | Zimmer Biomet, Inc. cable button for NCB Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001 Terminated |
HTN | K120772 |
| Aug 12, 2016 | Arthrex, Inc. Arthrex Suture Washer Terminated |
HTN | K043145 |
| Nov 26, 2013 | Synthes USA HQ, Inc. Synthes Spiked Washers 13.5/6.5
Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments. Terminated |
HTN | K011583 |
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