S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)

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

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for S-rom Femoral Hip Stem(sizes 12 X 06 X 115 And 12 X 07 X 115).

Pre-market Notification Details

• Device ID: K961939
• 510k Number: K961939
• Device Name: S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Contact: J. Theresa Dorriety, Esq.
• Correspondent: J. Theresa Dorriety, Esq.; JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Product Code: LPH
• Subsequent Product Code: LZO
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-05-20
• Decision Date: 1996-08-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295170938	K961939	000
10603295170921	K961939	000