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FDA 510(k)

POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX

K-Number: K033707 · 2004-08-16

ApplicantOsteobiologics, Inc.
Decision Date2004-08-16
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX is the device name listed in this FDA 510(k) record. The listed applicant is Osteobiologics, Inc.. It received FDA 510(k) clearance on 2004-08-16 under 510(k) number K033707. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX?

POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX is a medical device that received FDA 510(k) clearance on 2004-08-16. The listed applicant is Osteobiologics, Inc.. The 510(k) number is K033707.

When did POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX receive FDA 510(k) clearance?

POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX received FDA 510(k) clearance on 2004-08-16, under 510(k) number K033707.

Who is the listed applicant for POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX?

The FDA 510(k) record lists Osteobiologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX?

The FDA product code for POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX is MQV.

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Other records listing Osteobiologics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K051656OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEMK041382POLYGRAFT BGS; BONE GRAFT SUBSTITUTEK043172TRUGRAFT BGS SYRINGE, MODEL 600-041K040047POLYGRAFT BGS; BONE GRAFT SUBSTITUTEK032673IMMIX PLASTIFILMK030288POLYGRAFT BONE GRAFT SUBSTITUTE

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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