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RHEAD
 Request for Information Form |
 Contact Information
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| 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 | KWI |
| FDA Classification Name | PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 888.3170 |
| FDA Common Generic Name | ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS |
| FDA Proprietary Device Name | RHEAD |
| 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 |
Competitors of SMALL BONE INNOVATIONS, INC.
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 | ACUMED LLC 5885 NW CORNELIUS PASS RD. HILLSBORO, OR 97124 US 503-627-9957 / 503-627-9957 293 |
ACUMED ANATOMIC RADIAL HEAD SYSTEM | PROTHESIS, ELBOW JOINT RADIAL HEAD |
| 2 | ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 AUSTIN, TX 78754 US 512-836-5001 1513 / 512-836-5001 1513 |
ASCENSION MODULAR RADIAL HEAD | RADIAL HEAD PROSTHESIS |
| 3 | BIOMET UK LTD. WATERTON INDUSTRIAL ESTATE BRIDGEND SOUTH WALES, CF31 3XA UK 44-165-6655221 / 441-656-655221 |
BIOMET MERCK | STERILE RADIAL HEAD REPLACEMENT PROSTHESIS |
| 4 | BIOMET UK LTD. MURDOCK ROAD DORCAN INDUSTRIAL ESTATE SWINDON WILTSHIRE, SN3 5HY UK 44-165-6655221 / 441-656-655221 |
BIOMET MERCK | STERILE RADIAL HEAD REPLACEMENT PROSTHESIS |
| 5 | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 WARSAW, IN 46581 US 574-267-6639 / 574-372-1742 |
MODULAR RADIAL HEAD | VARIOUS TYPES OF ELBOW PROSTHESIS |
| 6 | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581 US 574-267-8143 4906 / 574-371-4906 |
MULTIPLE | VARIOUS TYPES OF ELBOW PROSTHESES, HEMI-RADIAL, POLYMER |
| 7 | HOWMEDICA INTERNATIONAL S. DE R.L., RAHEEN BUSNIESS PARK LIMERICK, EI 269-385-2600 / 201-831-5002 |
MULTIPLE | RADIAL HEAD |
| 8 | KAPP SURGICAL INSTRUMENT, INC. 4919 WARRENSVILLE CENTER RD. WARRENSVILLE HEIGHTS, OH 44128 US 216-587-4400 / 216-587-4400 |
KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT | RADIAL HEAD IMPLANT |
| 9 | KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD STE 180 CARLSBAD, CA 92011 US 609-275-0500 / 760-448-1706 |
KATALYST RADIAL HEAD IMPLANT | PASSIVE ORTHOPEDIC IMPLANT, ELBOW |
| 10 | SMITH & NEPHEW, INC. 1450 BROOKS RD. MEMPHIS, TN 38116 US 901-396-2121 / 901-399-5373 |
MULTIPLE | VARIOUS TYPES OF ELBOW PROSTHESES |
| 11 | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. ARLINGTON, TN 38002 US 901-867-4732 / 901-867-9971 |
METALLIC RADIAL HEAD IMPLANTS | METALLIC RADIAL HEAD |
| 12 | ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. PARSIPPANY, NJ 07054 US 800-613-6131 / 201-818-1800 |
UPPER EXTREMITY | RADIAL HEAD REPLACEMENT |
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