FDA 510(k), K002996, SYNERGY HA COATED POROUS FEMORAL STEMS

FDA 510(k), K002996, SYNERGY HA COATED POROUS FEMORAL STEMS

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510(K) Number: K002996
Device Name: SYNERGY HA COATED POROUS FEMORAL STEMS
Manufacturer:
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation Number: 888.3353
Classification Product Code: MEH
Date Received: 09/25/2000
Decision Date: 12/11/2000
Regulation Medical Specialty: Orthopedic

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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