RE-MOTION TOTAL WRIST MANUFACTURED BY SMALL BONE INNOVATIONS, INC.

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Request for Information Form	Contact Information
Company Name	SMALL BONE INNOVATIONS, INC.
Address	1380 S. PENNSYLVANIA AVE.
City, State, Zip	MORRISVILLE, PA 19067
Country	US
FDA Owner/Operator Phone	212-583-0250
FDA Medical Specialty Code	OR - Orthopedic
FDA Product Code	JWJ
FDA Classification Name	PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED
FDA Device Classification Code	Standards
FDA Regulation Number	888.3800
FDA Common Generic Name	WRIST JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS
FDA Proprietary Device Name	RE-MOTION TOTAL WRIST
FDA Owner / Operator Number	9049474
FDA Owner / Operator Name	SMALL BONE INNOVATIONS, INC.
FDA Establishment Registration Number	3003640913
FDA Registered Establishment Name	SMALL BONE INNOVATIONS, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	04-03-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	BIO-LOK INTL., INC. 312 & 368 SOUTH MILITARY TRAIL DEERFIELD BEACH, FL 33442 US 954-698-9998 / 954-698-9998	ARTICULATION, PROSTHESIS, WRIST, 3 PART METAL PLASTIC-METAL	ARTICULATION, PROSTHESIS, WRIST, 3 PART METAL PLASTIC-METAL ARTICULATION, SEMI-C
2	BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 WARSAW, IN 46581 US 574-267-6639 / 574-372-1742	MULTIPLE	VARIOUS TYPES OF WRIST PROSTHESIS
3	DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581 US 574-267-8143 4906 / 574-371-4906	MULTIPLE	VARIOUS WRIST PROSTHESES WITH STERILE AND NON-STERILE COMPONENTS
4	KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD STE 180 CARLSBAD, CA 92011 US 609-275-0500 / 760-448-1706	UNIVERSAL TOTAL WRIST SYSTEM	PASSIVE ORTHOPEDIC IMPLANT (WRIST)
5	SMITH & NEPHEW, INC. 1450 BROOKS RD. MEMPHIS, TN 38116 US 901-396-2121 / 901-399-5373	MULTIPLE	VARIOUS TYPES OF WRIST PROSTHESES
6	WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. ARLINGTON, TN 38002 US 901-867-4732 / 901-867-9971	TULEISNIK TOTAL WRIST PROSTHESIS	TOTAL WRIST PROSTHESIS
7	ZIMMER GMBH SULZER ALLEE 8 WINTERTHUR, CH-8404 SZ / 574-372-4485	MULTIPLE	VARIOUS