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FDA 510(k)

MOBILIMB-CPM UPPER/LOWER LIMB DEVICE

K-Number: K823495 · 1983-01-21

ApplicantSynthes (Usa)
Decision Date1983-01-21
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MOBILIMB-CPM UPPER/LOWER LIMB DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1983-01-21 under 510(k) number K823495. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBILIMB-CPM UPPER/LOWER LIMB DEVICE?

MOBILIMB-CPM UPPER/LOWER LIMB DEVICE is a medical device that received FDA 510(k) clearance on 1983-01-21. The listed applicant is Synthes (Usa). The 510(k) number is K823495.

When did MOBILIMB-CPM UPPER/LOWER LIMB DEVICE receive FDA 510(k) clearance?

MOBILIMB-CPM UPPER/LOWER LIMB DEVICE received FDA 510(k) clearance on 1983-01-21, under 510(k) number K823495.

Who is the listed applicant for MOBILIMB-CPM UPPER/LOWER LIMB DEVICE?

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

What is the FDA product code for MOBILIMB-CPM UPPER/LOWER LIMB DEVICE?

The FDA product code for MOBILIMB-CPM UPPER/LOWER LIMB DEVICE is BXB.

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Other records listing Synthes (Usa) 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.

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Related Devices (Code: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.

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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