ALLthread Peek-Optima
5 catalogue numbers from 904900P, listed by Biomet Orthopedics, United States, under Staple, Fixation, Bone. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Guangdong (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K071569 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 904900P | 5.5 MM | In distribution |
| 904932P | 5.5 MM | In distribution |
| 904923P | 6.8 MM | In distribution |
| 905942P | 5.5 MM | In distribution |
| 905941P | 6.8 MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DynaBridge | Fusion Orthopedics, LLC | 156 |
| Arthrex® | Arthrex, Inc. | 80 |
| Staple, Fixation, Bone | Smith & Nephew, Inc. | 59 |
| Compression Staple System | Tornier Inc. | 36 |
| UNI-Clip | Newdeal Sas | 35 |
| Z-Staple | Z-Medical Gmbh & Co. KG | 34 |
| Orbitum Staple System | CPM Medical Consultants, LLC. | 32 |
| OSStaple | Biomedical Enterprises, Inc. | 30 |
| Acumed | Acumed LLC | 30 |
| Stealthfix Intraosseous Fixation System | Medartis Inc. | 29 |
| Staple, Fixation, Bone | Stryker GmbH | 29 |
| Step Boss | Biomedical Enterprises, Inc. | 27 |
Showing 12 of 319. All products under Staple, Fixation, Bone
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2015-02-26 | Class II | Employee error | The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed. | 50 Units | 2016-01-12 |
| Biomet, Inc. | 510(k) number | 2012-01-25 | Not classified | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the Indications | 787 | 2013-04-12 |
| Biomet, Inc. | 510(k) number | 2012-01-25 | Not classified | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the Indications | 1414 | 2013-04-12 |
| Biomet, Inc. | 510(k) number | 2012-01-25 | Not classified | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the Indications | 944 | 2013-04-12 |
| Biomet, Inc. | 510(k) number | 2012-01-25 | Not classified | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the Indications | 837 | 2013-04-12 |
| Biomet, Inc. | 510(k) number | 2012-01-25 | Not classified | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the Indications | 11 | 2013-04-12 |
| Biomet, Inc. | 510(k) number | 2012-01-25 | Not classified | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the Indications | 15 | 2013-04-12 |
| Biomet, Inc. | 510(k) number | 2012-01-25 | Not classified | Packaging | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the Indications | 204 | 2013-04-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.