Shoulder Innovations InSet 135 Instrument Case/Tray 2L2HB00002

GUDID B1132L2HB000020

Shoulder Innovations - InSet 135 Instrument Case/Tray

Shoulder Innovations, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device IDB1132L2HB000020
NIH Device Record Key735761f5-2880-41ce-a5c6-9d99a55c4e36
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoulder Innovations InSet 135 Instrument Case/Tray
Version Model NumberInSet 135 Instrument Case/Tray
Catalog Number2L2HB00002
Company DUNS080404519
Company NameShoulder Innovations, 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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1132L2HB000020 [Primary]

FDA Product Code

KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B1132L2HB000020]

Moist Heat or Steam Sterilization

[B1132L2HB000020]

Moist Heat or Steam Sterilization

[B1132L2HB000020]

Moist Heat or Steam Sterilization

[B1132L2HB000020]

Moist Heat or Steam Sterilization

[B1132L2HB000020]

Moist Heat or Steam Sterilization

[B1132L2HB000020]

Moist Heat or Steam Sterilization

[B1132L2HB000020]

Moist Heat or Steam Sterilization

[B1132L2HB000020]

Moist Heat or Steam Sterilization

[B1132L2HB000020]

Moist Heat or Steam Sterilization

[B1132L2HB000020]

Moist Heat or Steam Sterilization

[B1132L2HB000020]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-22
Device Publish Date2025-12-12

Devices Manufactured by Shoulder Innovations, Inc.

B1132L1S0400020 - Shoulder Innovations InSet FxR 1352025-12-22 Shoulder Innovations - InSet FxR 135 - 4mmX135
B1132L1S0600020 - Shoulder Innovations InSet FxR 1352025-12-22 Shoulder Innovations - InSet FxR 135 - 6mmX135
B1132L1S0600030 - Shoulder Innovations InSet FxR 1852025-12-22 Shoulder Innovations - InSet FxR 185 - 6mmX185
B1132L1S0800020 - Shoulder Innovations InSet FxR 1352025-12-22 Shoulder Innovations - InSet FxR 135 - 8mmX135
B1132L1S0800030 - Shoulder Innovations InSet FxR 1852025-12-22 Shoulder Innovations - InSet FxR 185 - 8mmX185
B1132L1S1000020 - Shoulder Innovations InSet FxR 1352025-12-22 Shoulder Innovations - InSet FxR 135 -10mmX135
B1132L1S1000030 - Shoulder Innovations InSet FxR 1852025-12-22 Shoulder Innovations - InSet FxR 185 -10mmX185
B1132L1S1200020 - Shoulder Innovations InSet FxR 1352025-12-22 Shoulder Innovations - InSet FxR 135 -12mmX135
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