# K971481: Duralastic Anatomical Nasal Implants

- Pathway: 510(k) (Traditional)
- Applicant: Allied Biomedical Corp.
- Decided: Jul 18, 1997 after 86 days
- Product code: FZE (Prosthesis, Nose, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952705 (1995). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952705: Spirit Ridge Nasal Implant, Spirit Ridge Technologies (1995). Our OCR of the scanned summary read “K952705” beside “510(k)”; FDA’s K952705 is the only number that fits it and carries the summary’s name for the device. Summary page 1.

## Most influential descendants
- K973573: Duralastic Anatomical Nasal Implants (1997), 1 descendant of its own
- K090803: Hanson Medical Facial Implants (2010), 0 descendants of its own

## Indications for use
The Duralastic Anatomical Nasal Implants are intended to be used to augment or reconstruct the nasal bridge and nasal profile for cosmetic or reconstructive surgery.

Source page: https://510kreport.com/device/K971481
Methodology: https://510kreport.com/methodology