REVELATION STEM, MODEL 427-21/42-080/180

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

ENCORE MEDICAL, L.P.

The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Revelation Stem, Model 427-21/42-080/180.

Pre-market Notification Details

• Device ID: K083651
• 510k Number: K083651
• Device Name: REVELATION STEM, MODEL 427-21/42-080/180
• Classification: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
• Applicant: ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758
• Contact: Teffany Hutto
• Correspondent: Teffany Hutto; ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758
• Product Code: KWA
• Subsequent Product Code: KWZ
• Subsequent Product Code: LPH
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-09
• Decision Date: 2009-03-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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