(93 days)
The intended use for the 450mm it's is as a temporary ant to aid in the healing of lor fractures. I for children abo 110 130 ow 65 The 100mm Nancy Nail™ for small long bone with a long diaphysis. as carpal or tarsal bone
The I fancy Nail™ is a titanium alloy pin, available in two lengths: 450mm and 100mm The 450mm is available in five diameters: 2.0, 2.5, 3.0, 3.5, 4.0. The 100mm has a diameter of 1mm
The provided document does not contain information about acceptance criteria or a study that proves the device meets such criteria. It is a summary of safety and effectiveness for a medical device (Nancy Nail™ intramedullary elastic nail) under the K960642 submission. The document primarily focuses on:
- Manufacturer and Sponsor Identification: Contact details and registration numbers.
- Proprietary and Common Name: Nancy Nail™ (Intramedullary Elastic Nail).
- Classification: FDA classification as a Class II metallic bone fixation fastener (21 CFR Section 888.3040), specifically a flexible, metallic bone fixation pin.
- Intended Use: Temporary aid in healing long bone fractures for children (450mm nail for patients 110-130 lbs, under 65 inches; 100mm nail for small long bones like carpal or tarsal bones).
- Description: Titanium alloy pin available in two lengths (450mm and 100mm) and various diameters.
- Predicate Devices: Kirschner's Wire & Steinman Pin, Howmedica's Rush Nail.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows a logo with a stylized letter 'L' inside a partial circle. The 'L' is formed by two thick, parallel lines that create the shape. The circle is incomplete, with a gap at the top left, giving the impression that the 'L' is emerging from or connecting to the circle. The logo is in black and white, with the 'L' and circle being solid black against a white background.
A SUBSIDIARY OF GIROUP LANDANGER CAMUS
MAY 1 7 1996
8 - SUMMARY OF SAFETY & EFFECTIVENESS
| MANUFACTURERIDENTIFICATION | Landanger-LandosZ.I. La Vendue BP 8852003 Chaumont Cedex France |
|---|---|
| ESTABLISHMENTREGISTRATION NUMBER | 9007981 |
| SPONSOR IDENTIFICATION | Jean-Paul Burtin, C.E.O.Landos, Inc.100 Lindenwood DriveMalvern, PA 19355Phone: (610) 644-4670Fax: (610) 644-4429 |
| SPONSOR ESTABLISHMENTREGISTRATION NUMBER | 2530066 |
| OFFICIAL CONTACTPERSON | Norman F. Estrin, Ph.D., RACPresidentEstrin Consulting Group, Inc.9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Fax: (301) 294-0126 |
| PROPRIETARY NAME | Nancy Nail™ |
| COMMON NAME | Intramedullary Elastic Nail |
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8 - SUMMARY OF SAFETY & EFFECTIVENESS
CLASSIFICATION NAME FDA has classified smooth or AND REFERENCE threaded metallic bone fixation fastener in Class II 21 CFR Section 888.3040. The Nancy Nail™ classified as a flexible, metallic bon fixation pin. ' RODUCT CLASSIFICATIO 1988887 ODB PROPOSED REGULATORY 发展 Class II NEL CODE OR SE NIENDED USE The intended use for the 450mm it's is as a temporary ant to aid in the healing of lor fractures. I for children abo 110 130 ow 65 The 100mm Nancy Nail™ for small long bone with a long diaphysis. as carpal or tarsal bone ESCRIPTION The I fancy Nail™ is a titanium alloy pin, available in two lengths: 450mm and 100mm The 450mm is available in five diameters: 2.0, 2.5, 3.0, 3.5, 4.0. The 100mm has a diameter of 1mm REDICATE DEVICES Kirschner's Wire & Steinman Pin Howmedica's Rush Nail Nail
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.