| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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8-344
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| Standard | |
ISO 7153-1 Second edition 1991-04-01
Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)] |
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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.
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| Extent of Recognition
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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.
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §888.4540 |
Applier, Cerclage |
Class 1 |
HXN |
| §888.4540 |
Awl |
Class 1 |
HWJ |
| §888.4540 |
Bender |
Class 1 |
HXW |
| §888.4540 |
Bit, Drill |
Class 1 |
HTW |
| §888.4540 |
Brace, Drill |
Class 1 |
HXY |
| §888.4540 |
Broach |
Class 1 |
HTQ |
| §888.4540 |
Burr, Orthopedic |
Class 1 |
HTT |
| §888.4540 |
Corkscrew |
Class 1 |
HWI |
| §888.4540 |
Countersink |
Class 1 |
HWW |
| §888.4540 |
Crimper, Pin |
Class 1 |
HXQ |
| §888.4540 |
Cutter, Wire |
Class 1 |
HXZ |
| §888.4540 |
Driver, Prosthesis |
Class 1 |
HWR |
| §888.4540 |
Extractor |
Class 1 |
HWB |
| §888.4540 |
File |
Class 1 |
HTP |
| §888.4540 |
Holder, Needle; Orthopedic |
Class 1 |
HXK |
| §888.4540 |
Impactor |
Class 1 |
HWA |
| §888.4540 |
Instrument, Bending Or Contouring |
Class 1 |
HXP |
| §888.4540 |
Instrument, Compression |
Class 1 |
HWN |
| §888.4540 |
Knife, Orthopedic |
Class 1 |
HTS |
| §888.4540 |
Orthopedic Manual Surgical Instrument |
Class 1 |
LXH |
| §888.4540 |
Passer |
Class 1 |
HWQ |
| §888.4540 |
Passer, Wire, Orthopedic |
Class 1 |
HXI |
| §888.4540 |
Positioner, Socket |
Class 1 |
KIL |
| §888.4540 |
Probe |
Class 1 |
HXB |
| §888.4540 |
Punch, Femoral Neck |
Class 1 |
HWP |
| §888.4540 |
Pusher, Socket |
Class 1 |
HXO |
| §888.4540 |
Reamer |
Class 1 |
HTO |
| §888.4540 |
Rongeur |
Class 1 |
HTX |
| §888.4540 |
Scissors, Orthopedic, Surgical |
Class 1 |
HRR |
| §888.4540 |
Screwdriver |
Class 1 |
HXX |
| §888.4540 |
Set, Hollow Mill |
Class 1 |
HWL |
| §888.4540 |
Skid, Bone |
Class 1 |
HWO |
| §888.4540 |
Staple Driver |
Class 1 |
HXJ |
| §888.4540 |
Starter, Bone Screw |
Class 1 |
HWD |
| §888.4540 |
Stripper, Surgical |
Class 1 |
HRT |
| §888.4540 |
Tamp |
Class 1 |
HXG |
| §888.4540 |
Tap, Bone |
Class 1 |
HWX |
| §888.4540 |
Trephine |
Class 1 |
HWK |
| §888.4540 |
Twister, Wire |
Class 1 |
HXS |
| §888.4540 |
Wrench |
Class 1 |
HXC |
| §888.4300 |
Gauge, Depth |
Class 1 |
HTJ |
| §888.4800 |
Template |
Class 1 |
HWT |
|
| §878.4820 |
Guide, Drill, Ligament |
Class 1 |
LXI |
| §888.3050 |
Accessories, Fixation, Spinal Interlaminal |
Class 2 |
LYP |
| §888.4540 |
Accessories, Fixation, Spinal Intervertebral Body |
Class 1 |
LYQ |
| §888.4540 |
Bone Mill |
Class 1 |
LYS |
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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. |
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
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