K2M, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000004440 FEI 3008599177
K2M, Inc. is a medical device manufacturer based in the United States, with 970 devices listed in EUDAMED and FDA 510(k) (EU Class I; FDA Class II) and 39 FDA recalls as of 12 Nov 2026.
- Devices
- 970
- Registrations
- EUDAMEDFDA
- FDA recalls
- 393 ongoing
Registry facts
- Registries
- EUDAMED 846
- FDA 510(k) 124
- Device classes
- EU Class I 846
- FDA Class II 124
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN US-MF-000004440
- FDA FEI 3008599177
- DUNS 146060863
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI, FDA recalls
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.
Catalogue
Search and filter all 970 devicesShowing 1-50 of 970
Company details
- EUDAMED SRN
- US-MF-000004440
- FDA FEI number
- 3008599177
- DUNS number
- 146060863
- EUDAMED status
- Active
- EUDAMED registered name
- K2M, Inc.
- Registered address
- 600, Hope Parkway SE, 20175, Leesburg, United States
- Website
- www.vbspineco.com/
- Phone
- +1-866-526-4171
- PRRC contact
- Justin Eggleton
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 9 Aug 2027
BSI Group The Netherlands B.V. 2797 2 certificates
- MDR 758873 Active
Technical documentation EU MDR
- Issued
- 18 Jun 2026
- Expires
- 6 Dec 2028
- Reason
- Change approved
- MDR 747089 Expiring
Quality management system EU MDR
- Issued
- 25 Mar 2026
- Expires
- 9 Aug 2027
- Reason
- Ar data change
FDA recalls
FDA recall records list 39 recalls initiated by K2M, INC., the earliest on 2016-12-02 and the most recent on 2022-06-13. By recorded status: 3 ongoing and 36 terminated. The reasons filed fall into these groups: labeling or instructions for use, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 2
- 2020 27
- 2021 5
- 2022 3
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 13 Jun 2022 Z-1307-2022 Class II Ongoing Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue.
- 13 Jan 2022 Z-0705-2022 Class II Ongoing Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
- 13 Jan 2022 Z-0706-2022 Class II Ongoing Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
2021
- 8 Sep 2021 Z-0104-2022 Class II Terminated Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
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- 7 May 2021 Z-1695-2021 Class II Terminated Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
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- 7 May 2021 Z-1696-2021 Class II Terminated Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
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- 7 May 2021 Z-1697-2021 Class II Terminated Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
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- 16 Mar 2021 Z-1410-2021 Class II Terminated Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies
- 8 Sep 2021 Z-0104-2022 Class II Terminated Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
2020
- 14 Dec 2020 Z-0931-2021 Class II Terminated The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
- 4 Nov 2020 Z-0542-2021 Class II Terminated All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks
Show the 25 most recent of 39 recalls
2020
- 3 Nov 2020 Z-0520-2021 Class II Terminated Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.
- 13 Apr 2020 Z-2008-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2009-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2010-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2011-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2012-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2013-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2014-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2015-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2016-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2017-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2018-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2019-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2020-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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- 13 Apr 2020 Z-2021-2020 Class II Terminated The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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Frequently asked questions
How many devices does K2M, INC. have in the registry?
The registry currently lists 970 devices for K2M, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list K2M, INC.'s devices?
Among its 50 most recently registered devices, K2M, INC. has devices listed in EUDAMED (50 devices).
What risk classes do K2M, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for K2M, INC.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for K2M, INC.?
FDA recall records list 39 recalls initiated by K2M, INC., the most recent initiated on 13 Jun 2022. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for K2M, INC.?
EUDAMED lists 2 certificates for K2M, INC. (technical documentation; quality management system) under MDR. The most recent was issued on 18 Jun 2026.
What are the newest devices from K2M, INC. in the registry?
The most recently registered devices listed for K2M, INC. include MESA® Spinal System, ALEUTIAN® Interbody Systems, EVEREST® Spinal System and CAYMAN® Plate System.