Device
Laminar Rasp 1 (Sz 8,10,12)
Manufacturer
Spinal Simplicity, LLC
Model: 20-0216-000 DI: M9432002160000 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-05 Current Version: 2026-05-13
Description
Laminar Rasp 1 (Sz 8,10,12)
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 404fb26d-b78d-42f3-8e21-8539517123ff
Distribution Status: In Commercial Distribution
DUNS Number: 963359513
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: M9432002160000
Type: Primary
Issuing Agency: HIBCC
GMDN
Code: 17507
Name: Bone tap, reusable
Definition:
A surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.
FDA Product Codes
LXH
Orthopedic Manual Surgical Instrument