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FDA 510(k)

SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)

K-Number: K973868 · 1998-01-08

ApplicantOsteotech, Inc.
Decision Date1998-01-08
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Osteotech, Inc.. It received FDA 510(k) clearance on 1998-01-08 under 510(k) number K973868. 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 SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)?

SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) is a medical device that received FDA 510(k) clearance on 1998-01-08. The listed applicant is Osteotech, Inc.. The 510(k) number is K973868.

When did SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) receive FDA 510(k) clearance?

SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) received FDA 510(k) clearance on 1998-01-08, under 510(k) number K973868.

Who is the listed applicant for SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)?

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

What is the FDA product code for SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)?

The FDA product code for SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) is KWP.

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Other records listing Osteotech, 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.

K082615GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICESK081227PLEXUR MK080511PLEXUR-PK073405PLEXUR MK061982PLEXUR PK051188GRAFTON DBM

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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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