MANZA HEADS 103-50-050

GUDID 00841176103108

MANZA UNIPOLAR HEAD, 50MM

STINSON ORTHOPEDICS INC.

Metallic femoral head prosthesis
Primary Device ID00841176103108
NIH Device Record Keyef7df7c4-45bf-423d-94b8-1f3b0f1d83e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMANZA HEADS
Version Model Number103-50-050
Catalog Number103-50-050
Company DUNS080460688
Company NameSTINSON ORTHOPEDICS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841176103108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWLProsthesis, Hip, Hemi-, Femoral, Metal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-26

On-Brand Devices [MANZA HEADS]

00841176103207MANZA UNIPOLAR HEAD, 60MM
00841176103191MANZA UNIPOLAR HEAD, 59MM
00841176103184MANZA UNIPOLAR HEAD, 58MM
00841176103177MANZA UNIPOLAR HEAD, 57MM
00841176103160MANZA UNIPOLAR HEAD, 56MM
00841176103153MANZA UNIPOLAR HEAD, 55MM
00841176103146MANZA UNIPOLAR HEAD, 54MM
00841176103139MANZA UNIPOLAR HEAD, 53MM
00841176103122MANZA UNIPOLAR HEAD, 52MM
00841176103115MANZA UNIPOLAR HEAD, 51MM
00841176103108MANZA UNIPOLAR HEAD, 50MM
00841176103092MANZA UNIPOLAR HEAD, 49MM
00841176103085MANZA UNIPOLAR HEAD, 48MM
00841176103078MANZA UNIPOLAR HEAD, 47MM
00841176103061MANZA UNIPOLAR HEAD, 46MM
00841176103054MANZA UNIPOLAR HEAD, 45MM
00841176103047MANZA UNIPOLAR HEAD, 44MM
00841176103030MANZA UNIPOLAR HEAD, 43MM
00841176103023MANZA UNIPOLAR HEAD, 42MM
00841176103016MANZA UNIPOLAR HEAD, 41MM
00841176103009MANZA UNIPOLAR HEAD, 40MM
00841176101302MANZA COCR HEAD, 40, XL OFFSET
00841176101296MANZA COCR HEAD, 40, L OFFSET
00841176101289MANZA COCR HEAD, 40, M OFFSET
00841176101272MANZA COCR HEAD, 40, S OFFSET
00841176101265MANZA COCR HEAD, 36, XL OFFSET
00841176101258MANZA COCR HEAD, 36, L OFFSET
00841176101241MANZA COCR HEAD, 36, M OFFSET
00841176101234MANZA COCR HEAD, 36, S OFFSET
00841176101227MANZA COCR HEAD, 32, XL OFFSET
00841176101210MANZA COCR HEAD, 32, L OFFSET
00841176101203MANZA COCR HEAD, 32, M OFFSET
00841176101197MANZA COCR HEAD, 32, S OFFSET
00841176101180MANZA COCR HEAD, 28, L OFFSET
00841176101173MANZA COCR HEAD, 28, M OFFSET
00841176101166MANZA COCR HEAD, 28, S OFFSET
00841176103245MANZA TAPER SLEEVE OFFSET, +8MM
00841176103238MANZA TAPER SLEEVE OFFSET, +4MM
00841176103221MANZA TAPER SLEEVE OFFSET, 0MM
00841176103214MANZA TAPER SLEEVE OFFSET, -4MM
00841176101876MANZA BIOLOX DELTA HEAD OFFSET, 40 XL
00841176101869MANZA BIOLOX DELTA HEAD OFFSET, 40 L
00841176101852MANZA BIOLOX DELTA HEAD OFFSET, 40 M
00841176101845MANZA BIOLOX DELTA HEAD OFFSET, 40 S
00841176101838MANZA BIOLOX DELTA HEAD OFFSET, 36 XL
00841176101821MANZA BIOLOX DELTA HEAD OFFSET, 36 L
00841176101814MANZA BIOLOX DELTA HEAD OFFSET, 36 M
00841176101807MANZA BIOLOX DELTA HEAD OFFSET, 36 S
00841176101791MANZA BIOLOX DELTA HEAD OFFSET, 32 XL
00841176101784MANZA BIOLOX DELTA HEAD OFFSET, 32 L

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.