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FDA 510(k)

MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG

K-Number: K874911 · 1988-02-24

ApplicantWalter Lorenz Surgical, Inc.
Decision Date1988-02-24
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG is the device name listed in this FDA 510(k) record. The listed applicant is Walter Lorenz Surgical, Inc.. It received FDA 510(k) clearance on 1988-02-24 under 510(k) number K874911. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG?

MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG is a medical device that received FDA 510(k) clearance on 1988-02-24. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K874911.

When did MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG receive FDA 510(k) clearance?

MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG received FDA 510(k) clearance on 1988-02-24, under 510(k) number K874911.

Who is the listed applicant for MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG?

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

What is the FDA product code for MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG?

The FDA product code for MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG is HRX.

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Other records listing Walter Lorenz Surgical, 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.

K063386LORENZ ORTHODONTIC ANCHORAGE SYSTEMK063052LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATESK063506LORENZ STERNAL CLOSURE SYSTEMK062842TWIST DRILLK061384LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUMK042516OTOMIMIX

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Related Devices (Code: HRX)

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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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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