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FDA 510(k)

PWB LUMBOSACRAL SPINE SYSTEM

K-Number: K920116 · 1992-04-10

ApplicantCross Medical Products, Inc.
Decision Date1992-04-10
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PWB LUMBOSACRAL SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cross Medical Products, Inc.. It received FDA 510(k) clearance on 1992-04-10 under 510(k) number K920116. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PWB LUMBOSACRAL SPINE SYSTEM?

PWB LUMBOSACRAL SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 1992-04-10. The listed applicant is Cross Medical Products, Inc.. The 510(k) number is K920116.

When did PWB LUMBOSACRAL SPINE SYSTEM receive FDA 510(k) clearance?

PWB LUMBOSACRAL SPINE SYSTEM received FDA 510(k) clearance on 1992-04-10, under 510(k) number K920116.

Who is the listed applicant for PWB LUMBOSACRAL SPINE SYSTEM?

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

What is the FDA product code for PWB LUMBOSACRAL SPINE SYSTEM?

The FDA product code for PWB LUMBOSACRAL SPINE SYSTEM is KWP.

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Other records listing Cross Medical Products, 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.

K974749SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMSK973836SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEMK950709SYNERGY TI ANTERIOR SPINAL SYSTEMK940631CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEMK924381PWB LUMBAR LAMINAR HOOKS WITH SET SCREWSK895587CROSS MEDICAL PRODUCT PEDICLE AWL

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Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, 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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