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.
Indications for Use
Indicated for skeletally mature adults with discogenic back pain due to DDD at 1-2 contiguous levels (L1-S1), including those with up to Grade 1 Spondylolisthesis or retrolisthesis, who failed 6 months of non-operative treatment. Also indicated for anterior screw fixation to treat spinal instability (fracture, tumor, pseudoarthrosis, spondylolysis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed surgery).
Regulatory Classification
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)
Nvision Biomedical Technologies, Inc., Integral Titanium Cervical Interbody (K222015)
Submission Summary (Full Text)
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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
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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-
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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
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| 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) | ? |
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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
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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,
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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.
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
