(79 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI/ML terms or data processing related to AI/ML.
Yes
The device is described as a "single-use, temporary device used for fixation of the C1-C2 vertebrae" and is intended for use "in case of fracture or multi-operated back." Its purpose is to provide structural support and stabilization to the vertebrae, which is a therapeutic function aimed at facilitating fusion and healing.
No
The device is a C1-C2 clamp system used for fixation of vertebrae, not for diagnosis.
No
The device description clearly states it is a "Posterior C1-C2 Clamp System" consisting of physical components made of surgical implant titanium, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The J.B.S. Posterior C1-C2 Clamp System is a surgical implant used for the fixation of vertebrae. It is a physical device implanted into the body.
- Intended Use: The intended use is for the fixation of C1-C2 vertebrae in cases of fracture or multi-operated back. This is a surgical procedure, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, the device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Fixation of C1-C2 in case of fracture or multi-operated back.
Product codes
87KWP
Device Description
The J.B.S. Posterior C1-C2 Clamp System is a single-use. temporary device used for fixation of the C1-C2 vertebrae. The System is to be removed after fusion occurs. It consists of a cervical hook, a superior hook, a linking screw and a locking screw. All these components are made of surgical implant titanium with the composition Ti-6AL-4V ELI according to ASTM-136-92 or ISO 5832-3-90.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
C1-C2 vertebrae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
EXHIBIT C
Safe Medical Devices Act of 1990, 21 CFR 807.92
1455864
Company:
Regulatory Authority:
J.B.S. Parc d'activities Savipol 10300 Ste. Savine, Troyes Tel: 011-33-2571-2500 Fax: 011-33-2571-2506
Medical Device Establishment Registration #: 9681258
FDA Owner/Operator #:
9021265
Contact:
Trade Name:
Common Name: Cervical Clamp System
Classification Name: Appliance, Fixation, Spinal Interlaminal
Classification Code: 87KWP
Device Description: The J.B.S. Posterior C1-C2 Clamp System is a single-use. temporary device used for fixation of the C1-C2 vertebrae. The System is to be removed after fusion occurs. It consists of a cervical hook, a superior hook, a linking screw and a locking screw. All these components are made of surgical implant titanium with the composition Ti-6AL-4V ELI according to ASTM-136-92 or ISO 5832-3-90.
Ms. Liza Burns, Regulatory Consultant
J.B.S. POSTERIOR C1-C2 CLAMP SYSTEM®
Indications for use: Fixation of C1-C2 in case of fracture or multi-operated back.
Contraindications: The J.B.S. Posterior C1-C2 Clamp System is not to be used for patients with active localized or systemic infection, patients who are pregnant or patients who have a disease or other medical condition which inhibits the potential of bony fusion (i.e., osteoporosis, kidney dialysis, etc.).
Substantially Equivalent Devices:
- The APOFIX fixation device by Sofamor Danek (K945022) 2. The HALIFAX clamp
Distributed by Aesculap Aesculap Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080
Made in France by 1.8.8.