COMPRESS ANTI-ROTATION SPINDLES

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Compress Anti-rotation Spindles.

Pre-market Notification Details

• Device ID: K101475
• 510k Number: K101475
• Device Name: COMPRESS ANTI-ROTATION SPINDLES
• Classification: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
• Applicant: BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia Sandborn Beres
• Correspondent: Patricia Sandborn Beres; BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587
• Product Code: KWA
• Subsequent Product Code: JDI
• Subsequent Product Code: JDL
• Subsequent Product Code: KRO
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• Subsequent Product Code: LPH
• Subsequent Product Code: LZO
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-05-28
• Decision Date: 2010-06-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304509139	K101475	000
00880304509009	K101475	000
00880304508996	K101475	000
00880304508989	K101475	000
00880304508972	K101475	000
00880304508965	K101475	000
00880304508958	K101475	000
00880304508941	K101475	000
00880304508934	K101475	000
00880304508927	K101475	000
00880304508910	K101475	000
00880304509016	K101475	000
00880304509023	K101475	000
00880304509122	K101475	000
00880304509115	K101475	000
00880304509108	K101475	000
00880304509092	K101475	000
00880304509085	K101475	000
00880304509078	K101475	000
00880304509061	K101475	000
00880304509054	K101475	000
00880304509047	K101475	000
00880304509030	K101475	000
00880304508903	K101475	000