MAESTRO TOTAL WRIST

Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Maestro Total Wrist.

Pre-market Notification Details

• Device ID: K042032
• 510k Number: K042032
• Device Name: MAESTRO TOTAL WRIST
• Classification: Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
• Applicant: BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia Sandborn Beres
• Correspondent: Patricia Sandborn Beres; BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Product Code: JWJ
• CFR Regulation Number: 888.3800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-07-28
• Decision Date: 2004-10-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868239366	K042032	000
00887868239502	K042032	000
00887868239519	K042032	000
00887868239526	K042032	000
00887868239533	K042032	000
00887868239540	K042032	000
00887868239557	K042032	000
00887868239564	K042032	000
00887868239571	K042032	000
00887868239830	K042032	000
00887868239847	K042032	000
00887868239496	K042032	000
00887868239489	K042032	000
00887868239472	K042032	000
00887868239373	K042032	000
00887868239380	K042032	000
00887868239397	K042032	000
00887868239403	K042032	000
00887868239410	K042032	000
00887868239427	K042032	000
00887868239434	K042032	000
00887868239441	K042032	000
00887868239458	K042032	000
00887868239465	K042032	000
00887868239854	K042032	000
00880304269019	K042032	000
00880304439146	K042032	000
00880304439153	K042032	000
00880304439160	K042032	000
00880304439177	K042032	000
00880304439184	K042032	000
00880304439191	K042032	000
00880304439207	K042032	000
00880304439214	K042032	000
00880304481091	K042032	000
00880304481107	K042032	000
00880304439139	K042032	000
00880304439122	K042032	000
00880304439115	K042032	000
00880304269026	K042032	000
00880304269033	K042032	000
00880304269101	K042032	000
00880304269118	K042032	000
00880304439054	K042032	000
00880304439061	K042032	000
00880304439078	K042032	000
00880304439085	K042032	000
00880304439092	K042032	000
00880304439108	K042032	000
00880304481114	K042032	000