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K2M, INC.

Last updated September 17, 2026

Information

Country: US
Address: 600 Hope Pkwy SE, Leesburg, VA, 20175
Website: stryker.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(571)919-2000
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008599177
DUNS Number: 146060863

Catalogue (24835)

Page 5 of 497

Device	Model / Reference	Registries	Class	Status
PYRENEES® Cervical Plate System	SP-4112-11	FDA UDI	Class I	Active
CANYON™ Retractor Systems	SP-4114-05	FDA UDI	Class I	Active
YUKON OCT Spinal System	7601-15710	FDA UDI	Class II	Active
ALEUTIAN® Interbody Systems	402-90214	FDA UDI	Class II	Active
EVEREST® Spinal System	SP-4146-03	FDA UDI	Class I	Active
OZARK Cervical Plate System	8801-14517C	FDA UDI	Class II	Unknown
OZARK Cervical Plate System	8801-14319DA-G1	FDA UDI	Class II	Active
EVEREST® Spinal System	F2911-35550	FDA UDI	Class II	Active
CASCADIA™ Interbody System	402-90623	FDA UDI	Class II	Active
EVEREST® Spinal System	2901-86055DF	FDA UDI	Class II	Active
MESA® Spinal System	801-80803H-SG	FDA UDI	Class II	Active
MESA® Spinal System	801-05565-SG	FDA UDI	Class II	Active
ALEUTIAN® Interbody Systems	403-22015LB	FDA UDI	Class II	Active
ALEUTIAN® Interbody Systems	3303-20632W	FDA UDI	Class II	Active
EVEREST® Spinal System	2911-37530	FDA UDI	Class II	Active
CHESAPEAKE® Stabilization System	3608-207133	FDA UDI	Class II	Active
DENALI Spinal System	PRO-1006-02	FDA UDI	Class I	Active
MOJAVE Expandable Interbody System	7012-90042	FDA UDI	Class II	Active
CASCADIA™ Interbody System	6101-2224507LL8-G2	FDA UDI	Class II	Active
ALEUTIAN® Interbody Systems	403-21810P	FDA UDI	Class II	Active
EVEREST® Spinal System	5101-A60210-G1	FDA UDI	Class II	Active
YUKON OCT Spinal System	7601-03538	FDA UDI	Class II	Active
YUKON OCT Spinal System	7601-90094	FDA UDI	Class I	Active
CASCADIA™ Interbody System	6101-2162010CL25-G2	FDA UDI	Class II	Unknown
K2M General Instruments	PRO-1296-02	FDA UDI	Class I	Active
K2M General Instruments	PRO-1079-98	FDA UDI	Class I	Active
ATP Disc Prep	8030-10012	FDA UDI	Class I	Active
Navigated Spine Instruments	5101-N90005-K	FDA UDI	Class II	Active
OZARK Cervical Plate System	8801-04322DA	FDA UDI	Class II	Active
TERRA NOVA® MI Access System	1501-90095	FDA UDI	Class I	Active
EVEREST Spinal System	PRO-1226-02	FDA UDI	Class I	Active
Xia® 3 System - Serrato®	PRO-1370	FDA UDI	Class I	Active
SAHARA™ Stabilization System	7908-2D225516L10-G2	FDA UDI	Class II	Active
OZARK Cervical Plate System	8801-04521CA	FDA UDI	Class II	Active
MESA® Spinal System	6201-P6060	FDA UDI	Class II	Active
EVEREST® Spinal System	E5112-35535T	FDA UDI	Class II	Active
EVEREST® Spinal System	E5112-35550	FDA UDI	Class II	Active
MESA® Spinal System	6201-11155	FDA UDI	Class II	Active
ALEUTIAN® Interbody Systems	703-21130L15	FDA UDI	Class II	Active
PYRENEES® Cervical Plate System	201-14022C	FDA UDI	Class II	Active
ALEUTIAN® Interbody Systems	602-90404	FDA UDI	Class II	Active
ALEUTIAN® Interbody Systems	503-21727B	FDA UDI	Class II	Active
YUKON OCT Spinal System	7601-15709	FDA UDI	Class II	Active
MESA® Spinal System	6201-01055-G1	FDA UDI	Class II	Active
MESA® Spinal System	6201-P4520	FDA UDI	Class II	Active
ALEUTIAN® Interbody Systems	3303-90213	FDA UDI	Class II	Active
SANTORINI™ Corpectomy Cage System	1703-2242004	FDA UDI	Class II	Active
CHESAPEAKE® Stabilization System	3608-208153	FDA UDI	Class II	Active
EVEREST® Spinal System	2901-10001	FDA UDI	Class II	Active
CASCADIA™ Interbody System	6101-2121806HP-G2	FDA UDI	Class II	Active

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