| Device Type ID | 4575 |
| Device Name | Appliance, Fixation, Spinal Intervertebral Body |
| Regulation Description | Spinal Intervertebral Body Fixation Orthosis. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Anterior Spine Devices Branch (ASDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3060 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KWQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4575 |
| Device | Appliance, Fixation, Spinal Intervertebral Body |
| Product Code | KWQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Spinal Intervertebral Body Fixation Orthosis. |
| CFR Regulation Number | 888.3060 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALLIANCE PARTNERS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALPHATEC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALPHATEC HOLDINGS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AMENDIA, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ASTURA MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ATLAS SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET SPINE (AKA EBI, LLC) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAPTIVA SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CHOICE SPINE, LP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORENTEC CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEGEN MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EMINENT SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EVOLUTION SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EXACTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GENESYS SPINE | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INNOVASIS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTELLIGENT IMPLANT SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
K2M | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
K2M, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KALITEC MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
L&K BIOMED CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
L&K BIOMED CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LIFE SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDACTA INTERNATIONAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICAL DESIGNS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDITECH SPINE | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
MEDOS INTERNATIONAL SARL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDTRONIC SOFAMOR DANEK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
MEDYSSEY USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROSTRUCTURES, INC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NVISION BIOMEDICAL TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHOFIX | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ORTHOFIX INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHOFIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSSEUS FUSION SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRECISION SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RELIANCE MEDICAL SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RENOVIS SURGICAL TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEASPINE ORTHOPEDICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHANGHAI SANYOU MEDICAL CO, LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOLCO BIOMEDICAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEART | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPINEWAY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SURGICAL INSTRUMENT MANUFACTURERS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
U&I CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
U&I MEDICAL DEVICES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ULRICH MEDICAL USA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
X-SPINE SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
X-SPINE SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
XTANT MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZAVATION, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 296 |
Break | 279 |
Migration Or Expulsion Of Device | 187 |
Fracture | 131 |
Mechanical Problem | 79 |
Device Dislodged Or Dislocated | 59 |
Unintended Movement | 58 |
Device Operates Differently Than Expected | 56 |
Loose Or Intermittent Connection | 54 |
Screw | 47 |
Material Fragmentation | 43 |
Material Deformation | 42 |
Material Integrity Problem | 40 |
Migration | 35 |
Detachment Of Device Or Device Component | 33 |
Material Separation | 30 |
Device Slipped | 23 |
Bent | 23 |
Appropriate Term/Code Not Available | 19 |
Dull, Blunt | 17 |
Device-Device Incompatibility | 17 |
Insufficient Information | 16 |
Mechanical Jam | 15 |
Malposition Of Device | 13 |
Detachment Of Device Component | 12 |
Sticking | 11 |
Plate | 11 |
Naturally Worn | 11 |
Difficult To Remove | 10 |
Failure To Adhere Or Bond | 10 |
Failure To Osseointegrate | 9 |
Device Operational Issue | 8 |
Use Of Device Problem | 8 |
Device Damaged By Another Device | 8 |
Locking Mechanism | 8 |
Fitting Problem | 8 |
Loss Of Osseointegration | 8 |
Positioning Problem | 7 |
Material Twisted / Bent | 7 |
Improper Or Incorrect Procedure Or Method | 6 |
Torn Material | 6 |
Failure To Align | 5 |
Crack | 5 |
Material Distortion | 5 |
Ring | 5 |
Misconnection | 5 |
No Apparent Adverse Event | 5 |
Deformation Due To Compressive Stress | 4 |
Device Issue | 4 |
Difficult To Position | 4 |
Separation Problem | 3 |
Difficult To Advance | 3 |
Biocompatibility | 3 |
Rod | 3 |
Loosening Of Implant Not Related To Bone-Ingrowth | 3 |
Metal Shedding Debris | 3 |
Disassembly | 3 |
Contamination / Decontamination Problem | 3 |
Unstable | 3 |
Device Reprocessing Problem | 3 |
Material Disintegration | 3 |
Patient-Device Incompatibility | 2 |
Lock | 2 |
Corroded | 2 |
Material Discolored | 2 |
Unintended Ejection | 2 |
Peeled / Delaminated | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Component Falling | 2 |
Difficult To Insert | 2 |
Device Markings / Labelling Problem | 2 |
Entrapment Of Device | 1 |
Material Erosion | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Ejection Problem | 1 |
Defective Device | 1 |
Packaging Problem | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Component Or Accessory Incompatibility | 1 |
Spring | 1 |
Material Protrusion / Extrusion | 1 |
Degraded | 1 |
Component Missing | 1 |
Extrusion | 1 |
Fail-Safe Problem | 1 |
Material Frayed | 1 |
Misassembled | 1 |
Screw Head | 1 |
Difficult To Interrogate | 1 |
Product Quality Problem | 1 |
Device Inoperable | 1 |
Handpiece | 1 |
| Total Device Problems | 1876 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alliance Partners LLC | II | Jul-07-2015 |
| 2 | Alphatec Spine, Inc. | II | Apr-29-2015 |
| 3 | Amendia, Inc | II | Dec-22-2016 |
| 4 | Amendia, Inc Dba Spinal Elements | II | Dec-13-2017 |
| 5 | Biomet Spine, LLC | II | Nov-03-2015 |
| 6 | Biomet Spine, LLC | II | Sep-09-2015 |
| 7 | DePuy Spine, Inc. | II | Nov-19-2016 |
| 8 | DePuy Spine, Inc. | II | Dec-21-2015 |
| 9 | Exactech, Inc. | II | Jul-14-2015 |
| 10 | Innovasis, Inc | II | May-23-2017 |
| 11 | Medtronic Sofamor Danek USA Inc | II | May-08-2018 |
| 12 | Orthofix, Inc | II | Feb-25-2014 |
| 13 | SPINEART SA | II | Jan-13-2018 |
| 14 | Synthes (USA) Products LLC | II | Apr-20-2016 |
| 15 | Synthes, Inc. | II | Sep-22-2014 |
| 16 | Ulrich Medical USA Inc | II | Apr-26-2017 |
| 17 | Zimmer Biomet Spine Inc. | II | Feb-22-2019 |