S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

JOINT MEDICAL PRODUCTS CORP.

The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom 135 Femoral Stem & Collar(part Of S-rom Hip.

Pre-market Notification Details

• Device ID: K851422
• 510k Number: K851422
• Device Name: S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902
• Contact: Douglas G Noiles
• Correspondent: Douglas G Noiles; JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-04-10
• Decision Date: 1985-09-18

NIH GUDID Devices

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