FDA PRODUCT CODE · CLASS II
MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
What these counts are not
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
What this classification requires
Every statement below is FDA’s own classification record for this product code, quoted from the device classification field reference. The SPEQ reading beneath each one is SPEQ’s interpretation of what it means for the work, and is not FDA text.
510(K)
SPEQ READINGA premarket notification under 21 CFR Part 807 Subpart E is the route for this code. The submission argues substantial equivalence to a legally marketed predicate, so the engineering question is which predicate the design can actually be compared against, and the evidence question is what testing supports that comparison.
Class II (moderate to high risk): general controls and special controls
SPEQ READINGSpecial controls are the distinguishing feature: performance standards, guidance documents, patient registries or postmarket surveillance named for the device type. Find the special controls before designing the test plan — they usually name the tests.
Device is eligible for The Voluntary Malfunction Summary Reporting Program
SPEQ READINGMalfunctions for this code may be reported in periodic summary form rather than as individual MDRs under 21 CFR Part 803. Eligibility is a property of the product code; using it is a decision the manufacturer makes and must be able to justify.
Not exempt due to Good Manufacturing Practice (GMP)/Quality System
SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.
Device is implantable
SPEQ READINGImplant status raises the evidentiary bar on biocompatibility and on traceability from finished device back to material lot.
Device is not used for life sustaining purposes
SPEQ READINGNo life-sustaining designation attaches to this code.
Device is not a candidate for a third party review program
SPEQ READINGFDA reviews any premarket notification for this code directly.
Other product codes under 21 CFR 888.3080
One regulation usually governs several product codes. These share this code’s regulation, and therefore its classification basis.
21 CFR 888.3080 — Intervertebral body fusion device
The classification regulation for this product code, as published by the Office of the Federal Register. This is the regulation text itself — no SPEQ interpretation appears in it.
(a) 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.
(b) 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. [72 FR 32172, June 12, 2007]
Source: Electronic Code of Federal Regulations, Title 21. 21 CFR is a work of the United States Government and is in the public domain. SPEQ read this section on October 22, 2026. CFR is amended continuously, so verify against the source before acting on it: read 21 CFR 888.3080 on eCFR →
Recent clearances
Recent recalls
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
Complaints have been received regarding post-operative implant collapse.
Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
Inner blister pack label is incorrect and does not match the correct external box label.
Source: FDA device classification, 510(k)/PMA, and recall datasets. Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. Browse every product code SPEQ tracks →