Shoulder Innovations InSet Slap Hammer Rod 2L2HS00002

GUDID B1132L2HS000020

Shoulder Innovations - InSet Slap Hammer Rod

Shoulder Innovations, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device IDB1132L2HS000020
NIH Device Record Key8a6bb873-924b-4d48-b7d1-b75605f207fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoulder Innovations InSet Slap Hammer Rod
Version Model NumberSlap Hammer Rod
Catalog Number2L2HS00002
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 Numberfalse
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
HIBCCB1132L2HS000020 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B1132L2HS000020]

Moist Heat or Steam Sterilization

[B1132L2HS000020]

Moist Heat or Steam Sterilization

[B1132L2HS000020]

Moist Heat or Steam Sterilization

[B1132L2HS000020]

Moist Heat or Steam Sterilization

[B1132L2HS000020]

Moist Heat or Steam Sterilization

[B1132L2HS000020]

Moist Heat or Steam Sterilization

[B1132L2HS000020]

Moist Heat or Steam Sterilization

[B1132L2HS000020]

Moist Heat or Steam Sterilization

[B1132L2HS000020]

Moist Heat or Steam Sterilization

[B1132L2HS000020]

Moist Heat or Steam Sterilization

[B1132L2HS000020]

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.

B1132R1NET20360 - Shoulder Innovations Inset Reverse Total Shoulder2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Eccentric EZ Glenosphere - 36mm Diameter x 2mm Ecc x 0mm Lat
B1132R1NET30390 - Shoulder Innovations Inset Reverse Total Shoulder2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Eccentric EZ Glenosphere - 39mm Diameter x 3mm Ecc x 0mm Lat
B1132R1NET40420 - Shoulder Innovations Inset Reverse Total Shoulder2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Eccentric EZ Glenosphere - 42mm Diameter x 4mm Ecc x 0mm Lat
B1132R1NLT03330 - Shoulder Innovations Inset Reverse Total Shoulder2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Lateralized EZ Glenosphere - 33mm Diameter x 0mm Ecc x 3mm Lat
B1132R1NLT03360 - Shoulder Innovations Inset Reverse Total Shoulder2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Lateralized EZ Glenosphere - 36mm Diameter x 0mm Ecc x 3mm Lat
B1132R1NLT03390 - Shoulder Innovations Inset Reverse Total Shoulder2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Lateralized EZ Glenosphere - 39mm Diameter x 0mm Ecc x 3mm Lat
B1132R1NLT03420 - Shoulder Innovations Inset Reverse Total Shoulder2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Lateralized EZ Glenosphere - 42mm Diameter x 0mm Ecc x 3mm Lat
B1132R1NLT06330 - Shoulder Innovations Inset Reverse Total Shoulder2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Lateralized EZ Glenosphere - 33mm Diameter x 0mm Ecc x 6mm Lat
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