Product Code: HTP


Products Classified as HTP

4480FileOrthopedic Manual Surgical Instrument.

Total Product Life Cycle (TPLC) Devices

4480FileOrthopedic Manual Surgical Instrument.

FDA Consensus Standards

File [37411]21 CFR §888.4540 🔎
File [31853]21 CFR §888.4540 🔎
File [37809]21 CFR §888.4540 🔎
File [31985]21 CFR §888.4540 🔎
File [37414]21 CFR §888.4540 🔎

Pre-market Notifications for HTP

K931733INTERMEDICS ORTHOPEDICS REAMERSINTERMEDICS ORTHOPEDICS
K870842SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASPWARSAW ORTHOPEDIC, INC.
K862659CONCEPT ARTHROSCOPY RASPCONCEPT, INC.
K8419814MM & 5MM FILESTAINLESS MFG., INC.
K840492SUN-LITE BLUE SLITSUNCOAST MEDICAL MANUFACTURERS, INC.

Global Unique Device Identification Database

00812998033928File
00812998033911File
00812998033904File
00812998033898File
00812998033881File
00812998033874File
00812998033867File
00812998033850File
00812998033843File
00812998033836File
00812998033829File
00812998033812File
00812998033805File
00812998033799File
00812998033782File

Maude Adverse Events

PW BONE FILEDEPUY ORTHOPAEDICS INC US2019-10-07
PW BONE FILEDEPUY ORTHOPAEDICS INC US2018-11-06
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