Home › Device types › QWK
Prosthesis, Posterior Spinal Elements
FDA product code QWK · Class 3 · Unknown
90
Registered devices
49
Adverse events
1
Recalls
0
510(k) clearances
Devices with this code
Pedicle Awl — PREMIA SPINE LTDK-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA — PREMIA SPINE LTDTOPS Inserter — PREMIA SPINE LTDNiti#2 Wire, Blunt Blunt Tip, L=470, Ø1.5mm Over K-Wire — PREMIA SPINE LTDTap Ø 5.5 for Pendulum Adaptor — PREMIA SPINE LTDTOPS Instrumentation Container — PREMIA SPINE LTDDepth Gauge and Feeler — PREMIA SPINE LTDSST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power Drill — PREMIA SPINE LTDMIS Tower Guide — PREMIA SPINE LTDK-Wire, Blunt Blunt Tip, L=600, Ø1.7mm P.Drill — PREMIA SPINE LTDK-Wire, Blunt Sharp Tip, L=565, Ø1.6 -0.05 mm P.Drill — PREMIA SPINE LTDTOPS™ - 21 M — PREMIA SPINE LTDTorx Setscrew Inserter — PREMIA SPINE LTDTube for K-wire over a k-wire technique 470mm — PREMIA SPINE LTDDKWA T- Handle, Coupling Connection — PREMIA SPINE LTDLeft Alignment Gauge Superior Crossbars Medium — PREMIA SPINE LTDTap Ø 6.5 for Pendulum Adaptor — PREMIA SPINE LTDBall Sleeve Assy — PREMIA SPINE LTDCannulated screwdriver XL — PREMIA SPINE LTDNiti#1 Wire, Blunt Beveled Tip, L=470, Ø1.7mm Over K-Wire — PREMIA SPINE LTDLeft Alignment Gauge Superior Crossbars Long — PREMIA SPINE LTDCannulated Tap Ø6.5 XL — PREMIA SPINE LTDNiti#1 Wire, Blunt Sharp Tip, L=470, Ø1.7mm Over K-Wire — PREMIA SPINE LTDTOPS™ - 38 S — PREMIA SPINE LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-16 | PREMIA SPINE LTD | Potential for missing pins at tip of inserter. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.