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Guided Growth System

by Orthofix, Inc.

510(k) K093442

Guided Growth System is a Class II device made by Orthofix, Inc., cleared under FDA 510(k) K093442 on 10 Jun 2010, active as of 10 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 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK093442 Date10 Jun 2010ClearedStatusActive

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  • Withdrawn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
OBT
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

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

Cites

Cited by

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

Devices cleared under K093442

18 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 K093442
UDI-DISize and differences
GUIDED GROWTH PLATE SYSTEM 1
ORTHOFIX SRL
450336CE / 118053504367277
Single use: no
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-180010 / 118054242518082
Outer Diameter 2.4 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-180035 / 118054242518099
Outer Diameter 3.5 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-GP520CE / 118054242518075
Outer Diameter 3.2 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-T80024 / 118054242518402
Length 24 mm; Outer Diameter 4.5 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-T80032 / 118054242518419
Outer Diameter 4.5 mm; Length 32 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-T80036 / 118054242518426
Length 36 mm; Outer Diameter 4.5 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-T80116 / 118054242518433
Outer Diameter 4.5 mm; Length 16 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-T80124 / 118054242518440
Length 24 mm; Outer Diameter 4.5 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-T80132 / 118054242518457
Outer Diameter 4.5 mm; Length 32 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-T80136 / 118054242518464
Length 36 mm; Outer Diameter 4.5 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-T80212 / 118054242518327
Length 12 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-T80216 / 118054242518334
Length 16 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-T80220 / 118054242518341
Length 20 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-T80416 / 118054242518358
Length 16 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
99-T80422 / 118054242518365
Length 22 mm
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
GPQ800CE / 118054242513360
Single use: yes
On the market
Guided Growth Plate System 1
ORTHOFIX SRL
GPQ900CE / 118054242513377
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code OBT (Plate, Bone, Growth Control, Pediatric, Epiphysiodesis).

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →