PIVOT BIPOLAR FEMORAL HEAD

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

ORTHO DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Pivot Bipolar Femoral Head.

Pre-market Notification Details

• Device ID: K050966
• 510k Number: K050966
• Device Name: PIVOT BIPOLAR FEMORAL HEAD
• Classification: Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
• Applicant: ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020
• Contact: William J Griffin
• Correspondent: William J Griffin; ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020
• Product Code: KWY
• CFR Regulation Number: 888.3390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-04-18
• Decision Date: 2005-07-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00822409015443	K050966	000
00822409015245	K050966	000
00822409015238	K050966	000
00822409015221	K050966	000
00822409015214	K050966	000
00822409015207	K050966	000
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00822409015184	K050966	000
00822409015177	K050966	000
00822409015160	K050966	000
00822409015153	K050966	000
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00822409015139	K050966	000
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00822409015092	K050966	000
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00822409015405	K050966	000
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00822409015382	K050966	000
00822409015375	K050966	000
00822409015368	K050966	000
00822409015351	K050966	000
00822409015344	K050966	000
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00822409015283	K050966	000
00822409015276	K050966	000
00822409010226	K050966	000