(175 days)
No
The description focuses on the mechanical components of a surgical clamp system and makes no mention of AI or ML.
Yes
The device is described as "intended...to achieve posterior cervical stabilization," which is a therapeutic function.
No
This device is an implant for stabilization, not a device used to diagnose a medical condition.
No
The device description explicitly states it consists of physical components made from titanium alloy and commercially pure titanium (clamps and screws), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "posterior cervical stabilization" in patients with "cervical subluxations and dislocations." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details physical components like clamps and screws made of titanium alloy, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used directly on the patient's anatomy.
N/A
Intended Use / Indications for Use
The subject devices are intended for single use and are indicated for patients with cervical subluxations and dislocations from C1-C7 to achieve posterior cervical stabilization.
Product codes
Not Found
Device Description
The Osteonics" Halifax " Plus Interlaminar Clamp System consists of three sizes (C1, 7mm, and 13mm) of threaded and matching unthreaded clamps made from titanium alloy. The system also features three lengths (10, 20, and 30 mm) of associated threaded screws made from commercially pure titanium and used to secure the aforementioned sets of matching threaded and unthreaded clamps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical (C1-C7)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
As the components of the Osteonics" Halifax Plus Interlaminar Clamp System remain identical to those of the previously marketed, predicate AME Halifax " Plus Interlaminar Clamp System, which has been determined substantially equivalent via 510(k) Premarket Notification #K850039, no additional performance data is deemed necessary.
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
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510(k) Notification Summary of Safety and Effectiveness for the Osteonics Halifax Plus Interlaminar Clamp System
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|------------------------------------------------------------------|
| Contact Person: | Chuck Ryan
Regulatory Affairs Team Leader |
Date of Summary Preparation:
June 10, 1996
Device Identification
| Proprietary Name: | Osteonics Halifax Plus Interlaminar Clamp
System |
|--------------------------------|-----------------------------------------------------------|
| Common Name: | Spinal Fixation Components |
| Classification Name/Reference: | Spinal Interlaminal Fixation Orthosis
21 CFR §888.3050 |
Predicate Device Identification:
The components of the Osteonics Halifax Plus Interlaminar Clamp System are identical and thus substantially equivalent to those of the AME* Halifax* Plus Interlaminar Clamp System, which was determined substantially equivalent by the U.S. Food and Drug Administration (FDA) via 510(k) Premarket Notification #K850039. (Note: In K850039, the AME" Halifax " Plus Interlaminar Clamp System was identified as the Halifax Spinal Clamp System, manufactured by AME's predecessor, Levtech, Inc.)
Description of Devices:
The Osteonics" Halifax " Plus Interlaminar Clamp System consists of three sizes (C1, 7mm, and
1
13mm) of threaded and matching unthreaded clamps made from titanium alloy. The system also features three lengths (10, 20, and 30 mm) of associated threaded screws made from commercially pure titanium and used to secure the aforementioned sets of matching threaded and unthreaded clamps.
Intended Use:
The subject devices are intended for single use and are indicated for patients with cervical subluxations and dislocations from C1-C7 to achieve posterior cervical stabilization.
Statement of Technological Comparison:
The designs, materials, intended use, and general manufacturing processes characterizing the components of the Osteonics Halifax® Plus Interlaminar Clamp System are identical to those of the predicate AME Halifax Plus Interlaminar Clamp System.
Performance Data:
As the components of the Osteonics" Halifax Plus Interlaminar Clamp System remain identical to those of the previously marketed, predicate AME Halifax " Plus Interlaminar Clamp System, which has been determined substantially equivalent via 510(k) Premarket Notification #K850039, no additional performance data is deemed necessary.