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FDA 510(k)

MOA BONE / M-SPHERE

K-Number: K972143 · 1997-10-16

ApplicantIop, Inc.
Decision Date1997-10-16
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MOA BONE / M-SPHERE is the device name listed in this FDA 510(k) record. The listed applicant is Iop, Inc.. It received FDA 510(k) clearance on 1997-10-16 under 510(k) number K972143. The device is classified under product code HPZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOA BONE / M-SPHERE?

MOA BONE / M-SPHERE is a medical device that received FDA 510(k) clearance on 1997-10-16. The listed applicant is Iop, Inc.. The 510(k) number is K972143.

When did MOA BONE / M-SPHERE receive FDA 510(k) clearance?

MOA BONE / M-SPHERE received FDA 510(k) clearance on 1997-10-16, under 510(k) number K972143.

Who is the listed applicant for MOA BONE / M-SPHERE?

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

What is the FDA product code for MOA BONE / M-SPHERE?

The FDA product code for MOA BONE / M-SPHERE is HPZ.

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Other records listing Iop, 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.

K090078KERASYS BIOENGINEERED LAMELLAR PATCH GRAFTK062252MOLTENO3K053622SURGISIS OCULAR GRAFTK010852OSMED TISSUE EXPANDERK003646SUTUREGROOVE WEIGHT SIZING SETK994289SUTUREGROOVE

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Related Devices (Code: HPZ)

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.

K212741EZYPORFci (France Chirurgie Instrumentation) SasK123764DURETTE OCULAR IMPLANTOculo-Plastik, Inc.K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEXCeramisys, Ltd.K112176SILICONE SPHERESOculo Plastik, Inc.K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.K082850EYE SPHERESProduct and Educational Services, LLC

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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