Precision Ai PTY Ltd (contract manufacturer, Brisbane Queensland, AU): 9 new FDA device listings, incl. shoulder arthroplasty implantation system
Precision Ai PTY Ltd (Brisbane Queensland): 9 new FDA device listings, incl. shoulder arthroplasty implantation system. Its amount of 9 is top-decile (92nd percentile of 2,709 records). Dated 15 days ago, it is in the active follow-up window. Score 80/100. As of 2026-11-04, 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: 9 · 92th percentile of 2,709 DeviceEstablishmentPulse records · 4.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 24 related AU DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Precision Ai PTY Ltd |
| Owner / operator | Kico Knee Innovation Company |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Brisbane Queensland, AU |
| New listings | 9 |
| Devices | Shoulder Arthroplasty Implantation System; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Shoulder Prosthesis, Reverse Configuration |
| Product codes | QHE, KWS, PHX |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | ASTRA Portal Surgical Planning System |
| First new listing | 2026-10-21 |
| Latest new listing | 2026-10-21 |
| FDA registration number | 3031914485 |
| Registration expires | 2027-12-31 |
| amount percentile | 92th of 2,709 (median 2, 4.5x median) |
| Peer records CSV (25 AU records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-10-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (AU first): Makar Consulting PTY Ltd (foreign exporter, Belrose New Sout · Signature Orthopaedics PTY Limited (manufacturer, Sydney New · Kico Knee Innovation Company (manufacturer, Frenchs Forest N · Merit Medical Australia Pty Ltd. (foreign exporter, Braiside · EvERX PTY LTD (foreign exporter, Sydney New South Wales, AU) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Precision Ai PTY Ltd and 25 AU peers
- AU DeviceEstablishmentPulse records like this one: 25
- Precision Ai PTY Ltd's amount: 92nd percentile of 2,709 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every AU peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Precision Ai PTY Ltd in Brisbane Queensland?
Precision Ai PTY Ltd (Brisbane Queensland, AU), a contract manufacturer, added 9 FDA device listings on 2026-10-21.
How does Precision Ai PTY Ltd compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 9 is 4.5x the median of 2 across 2,709 records. It is 15 days old, still within a typical 45-day follow-up window. Its Score of 80/100 puts it among the stronger signals in this feed.
Precision Ai PTY Ltd vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Precision Ai PTY Ltd | Brisbane Queensland, AU | 9 | 92nd | 2026-10-21 |
| Biopro, Inc. | Port Huron, MI | 10 | 92nd | 2026-10-15 |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN | 4 | 83rd | 2026-10-16 |
| Cook Medical LLC | Bloomington, IN | 4 | 83rd | 2026-10-13 |
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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.