Chrysalis Intelligence · Sponsors · Zimmer Biomet Spine, Inc.

Zimmer Biomet Spine, Inc.

Westminister, CO, US · 5 510(k) clearances · 1 recalls

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Total clearances

5

2020-10-08 → 2021-08-27

Last 12 months

0

Product codes

4

Most recent

2021-08-27

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	2	2021-04-02
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	1	2021-08-27
MQV	Filler, Bone Void, Calcium Compound	Class II	Orthopedic	1	2021-05-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	1	2020-10-08

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2023-10-16

Date	Severity	Status	Recall #	Product	Code	Reason
2023-10-16	Class II	Ongoing	Z-0639-2024	Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System	—	Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description…

Filings

All 510(k) clearances (5)

Date	K-number	Device	Code	Class	Specialty
2021-08-27	K212023	Virage Navigation System	OLO	Class II	Neurology
2021-05-04	K203218	CaP Spheres Pellet Pack	MQV	Class II	Orthopedic
2021-04-02	K210275	Polaris Spinal System	NKB	Class II	Orthopedic
2021-01-28	K203507	Vitality® Spinal Fixation System	NKB	Class II	Orthopedic
2020-10-08	K202309	Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System	KWQ	Class II	Orthopedic