Lincotek (Wuxi) Co., Ltd. (contract manufacturer, Wuxi Jiangsu, CN): 6 new FDA device listings, incl. prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Lincotek (Wuxi) Co., Ltd. (Wuxi Jiangsu): 6 new FDA device listings, incl. prosthesis, hip, constrained, cemented or uncemented, metal/polymer. Its amount of 6 is above the median of 1 (88th percentile). Dated 115 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 6 · 88th percentile of 2,570 DeviceEstablishmentPulse records · 6.0x the median
Free preview: all 13 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Lincotek (Wuxi) Co., Ltd. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Wuxi Jiangsu, CN |
| New listings | 6 |
| Devices | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Product codes | KWZ, KWY, LPH, OQG, MAY, MEH |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| First new listing | 2026-07-13 |
| Latest new listing | 2026-07-13 |
| FDA registration number | 3021386586 |
| Registration expires | 2026-12-31 |
| amount percentile | 88th of 2,570 (median 1, 6.0x median) |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-07-13
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Lincotek (Wuxi) Co., Ltd. and 687 CN peers
- CN DeviceEstablishmentPulse records like this one: 687
- Lincotek (Wuxi) Co., Ltd.'s amount: 88th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $137,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Lincotek (Wuxi) Co., Ltd. in Wuxi Jiangsu?
Lincotek (Wuxi) Co., Ltd. (Wuxi Jiangsu, CN), a contract manufacturer, added 6 FDA device listings on 2026-07-13.
How does Lincotek (Wuxi) Co., Ltd. compare to other DeviceEstablishmentPulse records?
Its amount of 6 sits in the upper half (88th percentile) of 2,570 records; the median is 1. It is 115 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Lincotek (Wuxi) Co., Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Lincotek (Wuxi) Co., Ltd. | Wuxi Jiangsu, CN | 6 | 88th | 2026-07-13 |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN | 4 | 83rd | 2026-10-16 |
| Cook Medical LLC | Bloomington, IN | 4 | 83rd | 2026-10-13 |
| Swiss-American CDMO,LLC | Carrollton, TX | 4 | 83rd | 2026-10-12 |
Related records
DeviceEstablishmentPulse: Contract manufacturer DeviceEstablishmentPulse: Foreign establishment
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.