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FDA 510(k)

SPINAL SURGERY FRAME

K-Number: K882078 · 1988-06-16

ApplicantKarlin Technology, Inc.
Decision Date1988-06-16
Product CodeFWZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPINAL SURGERY FRAME is the device name listed in this FDA 510(k) record. The listed applicant is Karlin Technology, Inc.. It received FDA 510(k) clearance on 1988-06-16 under 510(k) number K882078. The device is classified under product code FWZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL SURGERY FRAME?

SPINAL SURGERY FRAME is a medical device that received FDA 510(k) clearance on 1988-06-16. The listed applicant is Karlin Technology, Inc.. The 510(k) number is K882078.

When did SPINAL SURGERY FRAME receive FDA 510(k) clearance?

SPINAL SURGERY FRAME received FDA 510(k) clearance on 1988-06-16, under 510(k) number K882078.

Who is the listed applicant for SPINAL SURGERY FRAME?

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

What is the FDA product code for SPINAL SURGERY FRAME?

The FDA product code for SPINAL SURGERY FRAME is FWZ.

Related Clinical Trials

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Other records listing Karlin Technology, 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.

K903969SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RETK893203BONE SCREWK893201BONE PLATEK882525SPINAL MICROKNIFEK882519X-RAY MARKERK882073SPINAL NEEDLE

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Related Devices (Code: FWZ)

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.

K960019RETRACTOR ARM CLAMPBiopsys Medical, Inc.K945415'LIL MAC ACCESSORY CLAMP(TM)D.L. Nelson and Assoc., Inc.K944779CARBON LIGHTS HAND SURGERY TABLEAllen Medical Systems, Inc.K935381KAPS POSITIONING ARMAndronic Devices, Ltd.K931037WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)Whitmore Ent., Inc.K926225SPONGE COUNTERAmerican Medical Manufacturer, Inc.

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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