Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Alphatec/Nexmed — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

36 daysmedian FDA review time

108 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K050830	ZODIAC SPINAL FIXATION SYSTEM	Alphatec/Nexmed	2005-06-22	82	0
K051286	ZODIAC SPINAL FIXATION SYSTEM	Alphatec/Nexmed	2005-06-17	30	0
K050553	NOVEL VBR SPINAL SYSTEM	Alphatec/Nexmed	2005-04-18	46	1
K050390	TAMARACK ANTERIOR THORACOLUNBAR	Alphatec/Nexmed	2005-03-14	26	0
K050078	ROC LUMBAR PLATING SYSTEM	Alphatec/Nexmed	2005-02-18	36	0
K042252	NEXFLEX TOTAL HIP SYSTEM	Alphatec/Nexmed	2004-12-06	108	0
K042673	ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM	Alphatec/Nexmed	2004-10-27	28	3
K042201	NOVEL VBR SPINAL SYSTEM	Alphatec/Nexmed	2004-10-07	55	0
K042440	ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM	Alphatec/Nexmed	2004-10-07	28	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda