← Product Code [OVD](/productcode/OVD) · K261408 # SABER-XA System (K261408) _Elevation Spine · OVD · Aug 3, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K261408 ## Device Facts - **Applicant:** Elevation Spine - **Product Code:** [OVD](/productcode/OVD.md) - **Decision Date:** Aug 3, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3080 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The Elevation Spine SABER-XA System is indicated for intervertebral fusion in patients with DDD at one or two contiguous levels from L1 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The SABER-XA Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.The Elevation Spine SABER-XA Anterior Lumbar Plate, when used with screws and without the SABER-XA spacer component, is intended for anterior screw fixation to the lumbosacral spine (L1-S1) to treat instability resulting from: fracture (including dislocation and subluxation), tumor, degenerative disc disease (as defined above), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery. The Anterior Lumbar Plate is not to be used alone with Spikes, but may be used in construct with the spacer and spikes.All interbody fusion constructs of SABER-XA System are intended to be used with FDA cleared supplemental fixation. ## Device Story SABER-XA System is an integrated fixation lumbar interbody and anterior lumbar plate system; includes expandable lumbar interbodies, anterior plates, and fixation implants. Interbody features additively manufactured endplates and traditionally manufactured internal components; plates and screws are traditionally manufactured. Used by surgeons in clinical settings for spinal fusion and stabilization. System components are available in various dimensions to match patient anatomy. Interbody spacers are filled with autograft or allogenic bone graft to promote fusion. Requires use with FDA-cleared supplemental fixation. Benefits include stabilization of the lumbosacral spine and facilitation of intervertebral fusion in patients with degenerative conditions or instability. ## Clinical Evidence Bench testing only. Testing included static and dynamic axial compression (ASTM F2077), static and dynamic compression shear (ASTM F2077), expulsion, subsidence (ASTM F2267), axial screw pushout, and plate dissociation. ## Technological Characteristics System includes expandable lumbar interbodies, anterior plates, and fixation screws. Materials include additively manufactured endplates and traditionally manufactured components. Testing performed per ASTM F2077 and ASTM F2267. Sterilization and packaging identical to reference device SABER-C. ## Regulatory Identification An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion. ## Special Controls *Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. ## Predicate Devices - Medtronic DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System ([K150135](/device/K150135.md)) - Globus Medical, Inc., MAGNIFY-S Spacer ([K203278](/device/K203278.md)) ## Reference Devices - Elevation Spine, SABER-C ([K250240](/device/K250240.md)) - Elevation Spine, SABER-C ([K260660](/device/K260660.md)) - Nvision Biomedical Technologies, Inc., Integral Titanium Cervical Interbody ([K222015](/device/K222015.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} ![LOGO](U.S. Food & Drug Administration) August 3, 2026 Elevation Spine % Jen McBride Regulatory Consultant MRC Global, LLC 9160 Hwy. 64 Suite 12 P.O. Box 330 Lakeland, Tennessee 38002 Re: K261408 Trade/Device Name: SABER-XA System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, KWQ, MAX Dated: July 6, 2026 Received: July 7, 2026 Dear Ms. McBride: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261408 - Jen McBride Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K261408 - Jen McBride Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # BRENT SHOWALTER -S Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261408 | ? | | Please provide the device trade name(s). | | ? | | SABER-XA System | | | | Please provide your Indications for Use below. | | ? | | The Elevation Spine SABER-XA System is indicated for intervertebral fusion in patients with DDD at one or two contiguous levels from L1 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The SABER-XA Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.The Elevation Spine SABER-XA Anterior Lumbar Plate, when used with screws and without the SABER-XA spacer component, is intended for anterior screw fixation to the lumbosacral spine (L1-S1) to treat instability resulting from: fracture (including dislocation and subluxation), tumor, degenerative disc disease (as defined above), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery. The Anterior Lumbar Plate is not to be used alone with Spikes, but may be used in construct with the spacer and spikes.All interbody fusion constructs of SABER-XA System are intended to be used with FDA cleared supplemental fixation. | | | | Please select the types of uses (select one or both, as applicable). | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? | {4} K261408 # 510(k) Summary SABER-XA System July 15, 2026 Company: Elevation Spine, Inc. 2511 Garden Rd, Suite B125 Monteray, CA 93940 Primary Contact: Jen McBride – Regulatory Consultant MRC Global 9160 Hwy 64, Ste 12 PO Box 330 Phone: (901) 481-5902 Email: jen.mcbride@AskMRCGlobal.com Company/Secondary John Kirwan Contact: VP R&D Elevation Spine, Inc jkirwan@elevationspine.com 413-427-6155 Trade Name: SABER-XA System Common Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar Appliance, fixation, spinal intervertebral body Classification: Class II Regulation: 21 CFR 888.3080 (Intervertebral Fusion Device With Integrated Fixation, Lumbar) 21 CFR 888.3060 (appliance, fixation, spinal intervertebral body) Panel: Orthopedic Product Code: OVD, KWQ, MAX Primary Predicate: Medtronic DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System – K150135 # Device Description: The SABER-XA System is an integrated fixation lumbar interbody and anterior lumbar plate system comprised of a collection of expandable lumbar interbodies, anterior plates, and fixation implants. The SABER-XA expandable interbody includes additively manufactured endplates and traditionally Page 1 of 3 {5} K261408 manufactured internal components; the anterior plate and fixation implants are traditionally manufactured. The interbody, plate, and fixation implants are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. # Indications for Use: The Elevation Spine SABER-XA System is indicated for intervertebral fusion in patients with DDD at one or two contiguous levels from L1 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The SABER-XA Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The Elevation Spine SABER-XA Anterior Lumbar Plate, when used with screws and without the SABER-XA spacer component, is intended for anterior screw fixation to the lumbosacral spine (L1-S1) to treat instability resulting from: fracture (including dislocation and subluxation), tumor, degenerative disc disease (as defined above), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery. The Anterior Lumbar Plate is not to be used alone with Spikes, but may be used in construct with the spacer and spikes. All interbody fusion constructs of SABER-XA System are intended to be used with FDA cleared supplemental fixation. # Substantial Equivalence: The subject Saber-XA components are substantially equivalent to the following predicate devices: Primary Predicate: - Medtronic DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System (K150135) Additional Predicate: - Globus Medical, Inc., MAGNIFY-S Spacer (K203278) Reference Devices: - Elevation Spine, SABER-C (K250240; K260660) - Nvision Biomedical Technologies, Inc., Integral Titanium Cervical Interbody (K222015) The subject components are similar in indications to the predicate devices. Device sizing, geometry, technological characteristics, and materials are similar to the predicate. Materials, Page 2 of 3 {6} K261408 subtractive manufacturing, sterilization, and packaging are identical to those of the reference Elevation SABER-C (K250240) and additive manufacturing materials and processes are identical to those for SABER-C (K260660) and similar to those of the Integral Titanium Cervical Interbody (K222015). # **Performance Testing:** The following bench performance testing has been conducted on the subject Saber-XA System: Static and Dynamic Axial Compression per ASTM F2077, Static and Dynamic Compression Shear per ASTM F2077, Expulsion, Subsidence per ASTM F2267, Axial screw pushout, and Plate dissociation. # **Conclusion:** Based on the performance analysis and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices. Page 3 of 3 --- **Source:** [https://fda.innolitics.com/device/K261408](https://fda.innolitics.com/device/K261408) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com