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FDA 510(k)

POLYMER OBL SB ANCHOR / SUTURE COMBINATION

K-Number: K982996 · 1999-03-04

ApplicantOrthopaedic Biosystems, Ltd.
Decision Date1999-03-04
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLYMER OBL SB ANCHOR / SUTURE COMBINATION is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Biosystems, Ltd.. It received FDA 510(k) clearance on 1999-03-04 under 510(k) number K982996. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYMER OBL SB ANCHOR / SUTURE COMBINATION?

POLYMER OBL SB ANCHOR / SUTURE COMBINATION is a medical device that received FDA 510(k) clearance on 1999-03-04. The listed applicant is Orthopaedic Biosystems, Ltd.. The 510(k) number is K982996.

When did POLYMER OBL SB ANCHOR / SUTURE COMBINATION receive FDA 510(k) clearance?

POLYMER OBL SB ANCHOR / SUTURE COMBINATION received FDA 510(k) clearance on 1999-03-04, under 510(k) number K982996.

Who is the listed applicant for POLYMER OBL SB ANCHOR / SUTURE COMBINATION?

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

What is the FDA product code for POLYMER OBL SB ANCHOR / SUTURE COMBINATION?

The FDA product code for POLYMER OBL SB ANCHOR / SUTURE COMBINATION is JDR.

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Other records listing Orthopaedic Biosystems, Ltd. 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.

K000797OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01K983169POLYMER THREADED ANCHORK982963POLYMER THREADED ANCHOR / SUTURE COMBINATIONK972326PEBA ANCHOR/SUTURE COMBINATIONK963420CANCELLOUS SCREW WASHERK963432GUIDE WIRES FOR CANNULATED SCREWS

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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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