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Biorci Screw

by Smith & Nephew, Inc.

510(k) K032224

Biorci Screw is a medical device (FDA Class II; FDA product code HWC, Screw, Fixation, Bone) made by Smith & Nephew, Inc., cleared under FDA 510(k) K032224 on 8 Aug 2003, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK032224 Date8 Aug 2003ClearedStatusActive

Official records

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  • Withdrawn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
HWC
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K032224

9 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K032224
UDI-DISize and differences
BIORCI 7207566
Smith & Nephew, Inc.
7207566 / 720756603596010435477 —On the market
BIORCI 7207581
Smith & Nephew, Inc.
7207581 / 720758103596010485588 —On the market
BIORCI 7207916
Smith & Nephew, Inc.
7207916 / 720791603596010000897 —On the market
BIORCI 7207918
Smith & Nephew, Inc.
7207918 / 720791803596010485540 —On the market
BIORCI 7207919
Smith & Nephew, Inc.
7207919 / 720791903596010485557 —On the market
BIORCI 7207920
Smith & Nephew, Inc.
7207920 / 720792003596010485595 —On the market
BIORCI 7207921
Smith & Nephew, Inc.
7207921 / 720792103596010485601 —No longer on the market
BIORCI 7207923
Smith & Nephew, Inc.
7207923 / 720792303596010485618 —On the market
BIORCI 7207924
Smith & Nephew, Inc.
7207924 / 720792403596010485564 —No longer on the market

Similar devices

Other devices filed under FDA product code HWC (Screw, Fixation, Bone).

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →