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ALPHATEC SPINE, INC.

1017 adverse events · 84 clearances · 10 recalls · 7 inspections · 3 compliance actions

Scorecard
Events per device across the 47,683-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0.004 ▼

212 in the last 12 months

Higher volume than 85% of companies with 10+ devices

Recalls per device

0 →

0 in the last 12 months

Higher volume than 97% of companies with 10+ devices

These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.

Devices
47,683 device records · ordered by linked event volume.
BrandModelProduct codesPrimary DILinked events
Invictus15100KWP NKB00190376137902131
Invictus17950-225HXX00190376473017109
Invictus17140OLO0019037619590289
Arsenal87134HXX0084096719790678
Invictus17950-NOLO0019037647520267
IdentiTi233-150OVD0019037638298257
Arsenal Deformity Spinal Fixation System47127KWP MNH MNI NKB OSH0084096712458246
Invictus17109-055HWX0019037619207941
Invictus17026HXX0019037623417535
Invictus17111HXX0019037619271034
Invictus17110HXX0019037619268031
Arsenal87011HXX0084485606956524
Invictus17806HXX0019037633168324
IdentiTi232-10-85-300OVD0019037636999020
SafeOpAIX11901ETN GWF IKN PDQ0019037633072319
SafeOp 3AIX11240ETN GWF GXY GXZ IKN PDQ0019037651750618
Invictus19807-30HWX0019037630151816
Invictus17138HXX0019037618581115
Invictus17830HXX0019037641912114
Insignia236-1-24018KWQ0019037632979613
Arsenal87771OLO0019037600296512
IdentiTi232-10-85-250OVD0019037636997611
Invictus17139-045-NOLO0019037631920911
Invictus17109-045HWX0019037619205511
Invictus17001-01HXB0019037619564311
Arsenal87107-055HWX0084096712683810
Invictus17139-055-NOLO0019037631922310
Arcus16122-02-SETN PDQ001903762402759
Arcus16122-01-SETN PDQ001903762402688
Arsenal87013HXX008448560695898
Showing 1–30 of 47,683Next →
Compliance actions
FDA warning letters and enforcement actions (full history).
DateTypeActionFirm
2015-07-16WLWarning LetterAlphatec Spine, Inc.
2011-01-11WLWarning LetterAlphatec Spine, Inc.
2010-06-21WLWarning LetterAlphatec Spine, Inc.
Facilities
Registered establishments with their latest FDA inspection outcome.

No registered facilities linked.