INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

EXACTECH, INC.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Integrip Acetabular Shell, Integrip Revision Acetabular Shell.

Pre-market Notification Details

• Device ID: K122798
• 510k Number: K122798
• Device Name: INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Contact: Amy Taulbee
• Correspondent: Amy Taulbee; EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: KWZ
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-09-12
• Decision Date: 2012-10-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885862244437	K122798	000
10885862233219	K122798	000
10885862233202	K122798	000
10885862233196	K122798	000
10885862233189	K122798	000
10885862220554	K122798	000
10885862220547	K122798	000
10885862220530	K122798	000
10885862220523	K122798	000
10885862220516	K122798	000
10885862220509	K122798	000
10885862220493	K122798	000
10885862220486	K122798	000
10885862220479	K122798	000
10885862220462	K122798	000
10885862233226	K122798	000
10885862233233	K122798	000
10885862233240	K122798	000
10885862244420	K122798	000
10885862244413	K122798	000
10885862244406	K122798	000
10885862244390	K122798	000
10885862244383	K122798	000
10885862244376	K122798	000
10885862244369	K122798	000
10885862244352	K122798	000
10885862244345	K122798	000
10885862244338	K122798	000
10885862233288	K122798	000
10885862233271	K122798	000
10885862233264	K122798	000
10885862233257	K122798	000
10885862220455	K122798	000