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Polymer Obl Sb Anchor / Suture Combination

by Orthopaedic Biosystems, Ltd.

510(k) K982996

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982996 Date4 Mar 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JDR
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Polymer OBL SB Anchor/Suture Combination is a Staple, Fixation, Bone device (product code JDR), designed for soft tissue-to-bone fixation. It consists of a sterile, single-use polyacetal cylinder anchor preloaded with braided polyester suture, enabling secure attachment of soft tissues to bone.

This system is supplied with a manual insertion tool featuring a polypropylene handle and a stainless steel sleeve/piston. Sterile, single-use, and intended for orthopedic applications, it requires no additional regulatory approval beyond its FDA 510(k) clearance (K982996). Storage and handling follow standard sterile medical device protocols.

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