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Sign in to claim this brandK2M, INC.
US
Last updated September 17, 2026
What K2M, INC. makes
K2M, Inc. manufactures spinal fixation hardware, including non-bioabsorbable bone screws, vertebral body prostheses, and spinal plates for internal stabilization. Their portfolio also includes reusable orthopaedic instruments for prosthesis implantation, interbody systems for spinal fusion, and retractors for surgical exposure. Trial implants for spinal procedures and fixation rods for rod-screw systems are also part of their product line.
These devices are regulated under the FDA’s UDI system, with classifications spanning Class I and Class II. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their authorised status under US medical device regulations. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does K2M, Inc. manufacture?
K2M, Inc. specializes in spinal fixation and orthopaedic hardware. Their devices include non-bioabsorbable spinal bone screws, vertebral body prostheses (like cages for spinal fusion), spinal plates for internal stabilization, and reusable surgical instruments such as retractors and positioning tools for orthopaedic procedures. They also produce interbody systems for spinal fusion, trial implants for procedure planning, and fixation rods for spinal stabilization systems.
Where is K2M, Inc. based, and how does that affect its regulatory standing?
K2M, Inc. is headquartered in the United States. Since it operates within the US market, its devices are subject to FDA regulations, including the Unique Device Identifier (UDI) system. The company’s products are listed in the FDA’s UDI database, which helps track authorised devices under US medical device laws. This listing reflects compliance with FDA requirements for device identification and traceability.
Which regulatory registries or databases list K2M, Inc.’s devices?
K2M, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a regulatory requirement in the US to improve device tracking, transparency, and post-market surveillance. Listing in this database confirms the devices meet FDA standards for identification and classification, though it does not imply individual device approval.
How are K2M, Inc.’s devices classified under FDA regulations?
K2M, Inc.’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose minimal risk and may have fewer regulatory controls, while Class II devices require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as spinal hardware for stabilization or fusion.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 600 Hope Pkwy SE, Leesburg, VA, 20175
- Website
- stryker.com
- —
- —
- [email protected]
- Phone
- +1(571)919-2000
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3008599177
- DUNS Number
- 146060863
Catalogue (24835)
Page 34 of 497| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CHESAPEAKE® Stabilization System | 3608-90138 | FDA UDI | Class II | Active |
| CASCADIA™ Interbody System | 6101-2852808NT6-G2 | FDA UDI | Class II | Active |
| DENALI® MI Spinal System | M101-07550 | FDA UDI | Class II | Active |
| EVEREST Spinal System | 2901-90090 | FDA UDI | Class I | Active |
| EVEREST Spinal System | PRO-1399-03 | FDA UDI | Class I | Active |
| CAPRI Corpectomy Cage System | 2112-90011 | FDA UDI | Class I | Active |
| SANTORINI™ Corpectomy Cage System | 1708-90083 | FDA UDI | Class II | Active |
| ALEUTIAN Interbody Systems | K2-07-2099-01 | FDA UDI | Class I | Active |
| ALEUTIAN® Interbody Systems | SP-4214-127 | FDA UDI | Class II | Active |
| NIAGARA® Lateral Access System | AC01-90042 | FDA UDI | Class I | Active |
| OZARK Cervical Plate System | 8801-04323C | FDA UDI | Class II | Unknown |
| NAPA Access System | 8030-90074 | FDA UDI | Class I | Active |
| OZARK Cervical Plate System | 8801-14518C | FDA UDI | Class II | Unknown |
| CAPRI™ Corpectomy Cage System | 7501-21619L30-G2 | FDA UDI | Class II | Active |
| K2M General Instruments | PRO-1180-17 | FDA UDI | Class I | Active |
| EVEREST® Spinal System | ME5112-09550 | FDA UDI | Class II | Active |
| EVEREST® Spinal System | F2911-08525 | FDA UDI | Class II | Active |
| ALEUTIAN® Interbody Systems | 403-22015P | FDA UDI | Class II | Active |
| K2M General Instruments | PRO-1144-01 | FDA UDI | Class I | Active |
| Navigated Spine Instruments | 6201-N90014-K | FDA UDI | Class II | Active |
| OZARK Cervical Plate System | 8801-04024CA-G1 | FDA UDI | Class II | Active |
| CHESAPEAKE® Stabilization System | 3613-21113F | FDA UDI | Class II | Active |
| EVEREST® Spinal System | M5111-01090-G1 | FDA UDI | Class II | Active |
| ALEUTIAN® Interbody Systems | 403-21814 | FDA UDI | Class II | Active |
| CASCADIA™ Interbody System | 6101-2103208NL18-G2 | FDA UDI | Class II | Active |
| CAPRI™ Corpectomy Cage System | 7501-22039L7-G2 | FDA UDI | Class II | Active |
| Cascadia™ Interbody System | SP-2437-55 | FDA UDI | Class II | Active |
| EVEREST® Spinal System | SP-1459 | FDA UDI | Class I | Active |
| OZARK Cervical Plate System | SP-4065-04 | FDA UDI | Class I | Active |
| CASCADIA Interbody System | 6101-2185008LP-G2 | FDA UDI | Class II | Active |
| EVEREST® Spinal System | M5111-37565 | FDA UDI | Class II | Active |
| CANYON™ Retractor Systems | AN01-91418 | FDA UDI | Class I | Active |
| OZARK Cervical Plate System | 8801-14520CA | FDA UDI | Class II | Active |
| EVEREST® Spinal System | M5111-06550-G1 | FDA UDI | Class II | Active |
| CANYON™ Retractor Systems | 6401-90169 | FDA UDI | Class I | Active |
| CASPIAN® Spinal System | 1101-03536FN | FDA UDI | Class II | Active |
| ALEUTIAN® Interbody Systems | 3201-91004 | FDA UDI | Class I | Active |
| ALEUTIAN® Interbody Systems | 3303-90175 | FDA UDI | Class II | Active |
| ALEUTIAN® Interbody Systems | 3303-90353 | FDA UDI | Class II | Active |
| YUKON OCT Spinal System | 7611-63530-G1 | FDA UDI | Class II | Active |
| CASCADIA™ Interbody System | 6101-90167 | FDA UDI | Class II | Active |
| MESA® Spinal System | 6201-165105 | FDA UDI | Class II | Active |
| CASCADIA™ Interbody System | 6101-2185007LL8-G2 | FDA UDI | Class II | Active |
| ALEUTIAN® Interbody Systems | 5203-90039 | FDA UDI | Class II | Active |
| ALEUTIAN® Interbody Systems | 702-90181 | FDA UDI | Class I | Active |
| ALEUTIAN® Interbody Systems | 3201-90437 | FDA UDI | Class II | Active |
| K2M General Instruments | PRO-1122-09 | FDA UDI | Class I | Active |
| NIAGARA Lateral Access System | PRO-1265-17 | FDA UDI | Class I | Active |
| YUKON OCT Spinal System | 7601-73520-G1 | FDA UDI | Class II | Active |
| CASCADIA™ Interbody System | 6101-2122816TL7-G2 | FDA UDI | Class II | Unknown |
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