Model: 1500-1015
DI: 00840097513218
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
Screw Baseplate, 15 mm
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ed320902-fb52-4203-9d3a-302865ea5023
Distribution Status:
In Commercial Distribution
DUNS Number:
080819836
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00840097513218
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 33711
Name: Total reverse shoulder prosthesis
Definition:
A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted with or without bone cement.
FDA Product Codes
PHX
Shoulder Prosthesis, Reverse Configuration
Premarket Submissions
Submission Number:
K243643
Supplement Number:
000