| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
034
|
Date of Entry 01/30/2014
|
|
FR Recognition Number
|
8-344
|
| Standard | |
ISO 7153-1 Second edition 1991-04-01
Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)] |
|
Scope/AbstractThis part of ISO 7153 contains a survey and a selection of stainless steels available for use in the manufacture of surgical, dental and specific instruments for orthopaedic surgery.
|
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §878.4820 |
Guide, Drill, Ligament
|
Class 1
|
LXI
|
| §888.3050 |
Accessories, Fixation, Spinal Interlaminal
|
Class 2
|
LYP
|
| §888.4300 |
Gauge, Depth
|
Class 1
|
HTJ
|
| §888.4540 |
Scissors, Orthopedic, Surgical
|
Class 1
|
HRR
|
| §888.4540 |
Stripper, Surgical
|
Class 1
|
HRT
|
| §888.4540 |
Reamer
|
Class 1
|
HTO
|
| §888.4540 |
File
|
Class 1
|
HTP
|
| §888.4540 |
Broach
|
Class 1
|
HTQ
|
| §888.4540 |
Knife, Orthopedic
|
Class 1
|
HTS
|
| §888.4540 |
Burr, Orthopedic
|
Class 1
|
HTT
|
| §888.4540 |
Bit, Drill
|
Class 1
|
HTW
|
| §888.4540 |
Rongeur
|
Class 1
|
HTX
|
| §888.4540 |
Impactor
|
Class 1
|
HWA
|
| §888.4540 |
Extractor
|
Class 1
|
HWB
|
| §888.4540 |
Starter, Bone Screw
|
Class 1
|
HWD
|
| §888.4540 |
Corkscrew
|
Class 1
|
HWI
|
| §888.4540 |
Trephine
|
Class 1
|
HWK
|
| §888.4540 |
Set, Hollow Mill
|
Class 1
|
HWL
|
| §888.4540 |
Instrument, Compression
|
Class 1
|
HWN
|
| §888.4540 |
Skid, Bone
|
Class 1
|
HWO
|
| §888.4540 |
Punch, Femoral Neck
|
Class 1
|
HWP
|
| §888.4540 |
Passer
|
Class 1
|
HWQ
|
| §888.4540 |
Driver, Prosthesis
|
Class 1
|
HWR
|
| §888.4540 |
Countersink
|
Class 1
|
HWW
|
| §888.4540 |
Tap, Bone
|
Class 1
|
HWX
|
| §888.4540 |
Probe
|
Class 1
|
HXB
|
| §888.4540 |
Wrench
|
Class 1
|
HXC
|
| §888.4540 |
Tamp
|
Class 1
|
HXG
|
| §888.4540 |
Passer, Wire, Orthopedic
|
Class 1
|
HXI
|
| §888.4540 |
Staple Driver
|
Class 1
|
HXJ
|
| §888.4540 |
Holder, Needle; Orthopedic
|
Class 1
|
HXK
|
| §888.4540 |
Applier, Cerclage
|
Class 1
|
HXN
|
| §888.4540 |
Pusher, Socket
|
Class 1
|
HXO
|
| §888.4540 |
Instrument, Bending Or Contouring
|
Class 1
|
HXP
|
| §888.4540 |
Crimper, Pin
|
Class 1
|
HXQ
|
| §888.4540 |
Twister, Wire
|
Class 1
|
HXS
|
| §888.4540 |
Bender
|
Class 1
|
HXW
|
| §888.4540 |
Screwdriver
|
Class 1
|
HXX
|
| §888.4540 |
Brace, Drill
|
Class 1
|
HXY
|
| §888.4540 |
Cutter, Wire
|
Class 1
|
HXZ
|
| §888.4540 |
Positioner, Socket
|
Class 1
|
KIL
|
| §888.4540 |
Orthopedic Manual Surgical Instrument
|
Class 1
|
LXH
|
| §888.4540 |
Awl
|
Class 1
|
HWJ
|
| §888.4540 |
Bone Mill
|
Class 1
|
LYS
|
| §888.4540 |
Accessories, Fixation, Spinal Intervertebral Body
|
Class 1
|
LYQ
|
| §888.4800 |
Template
|
Class 1
|
HWT
|
|
Relevant FDA Guidance and/or Supportive Publications*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
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|
