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Spine Planning (3.0)

by Brainlab SE

510(k) K262257

Spine Planning (3.0) is a Class II device made by Brainlab SE, cleared under FDA 510(k) K262257 on 30 Sep 2026, 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 · Traditional NumberK262257 Date30 Sep 2026ClearedStatusActive

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  • Withdrawn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
OLO
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Devices cleared under K262257

91 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 K262257
UDI-DISize and differences
Adapter For Doro Skull Clamp 19153-02
Brainlab SE
19153-02 / 19153-0204056481004521
Prescription: yes; Single use: no
On the market
Adapter For Mayfield Skull Clamp 19153-01
Brainlab SE
19153-01 / 19153-0104056481004538
Prescription: yes; Single use: no
On the market
ADAPTER SHORT FOR PATIENT REFERENCE CLAMP 55761-01B
Brainlab SE
55761-01B04056481146603
Prescription: yes; Single use: no
On the market
AWL (3.0 MM) FOR OPEN SURGERY 55830-35A
Brainlab SE
55830-35A / 55830-35A04056481001216
Prescription: yes; Single use: no
On the market
AWL (4.0 MM) FOR OPEN SURGERY 55830-30A
Brainlab SE
55830-30A / 55830-30A04056481001223
Prescription: yes; Single use: no
On the market
Base Short For Drapelink 19153-04
Brainlab SE
19153-04 / 19153-0404056481004507
Prescription: yes; Single use: no
On the market
Buzz Navigation (Ceiling Mounted) 15706
Brainlab SE
15706 / 1570604056481140847
Prescription: yes; Single use: no
On the market
C-ARM ADAPTER ZIEHM RFD 3D LEFT 19154-04
Brainlab SE
19154-04 / 19154-0404056481113926
Prescription: yes; Single use: no
On the market
C-ARM REFERENCE UNIT RIGHT 19154-01
Brainlab SE
19154-01 / 19154-0104056481113957
Prescription: yes; Single use: no
On the market
Calibration Phantom Ict 19148-01A
Brainlab SE
19148-01A / 19148-01A04056481004569
Prescription: yes; Single use: no
On the market
CHISEL LONG FOR OPEN SURGERY 55830-50
Brainlab SE
55830-50 / 55830-5004056481001179
Prescription: yes; Single use: no
On the market
Cranial Reference Array Drapelink 19152-02
Brainlab SE
19152-02 / 19152-0204056481004545
Prescription: yes; Single use: no
On the market
Curve Navigation 17700 17701
Brainlab SE
1770104056481144500
Prescription: yes; Single use: no
On the market
DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS) 54929
Brainlab SE
5492904056481145200
Prescription: yes; Single use: yes
On the market
Drapelink Interface Ict Calib Phantom 19142-06
Brainlab SE
19142-06 / 19142-0604056481004637
Prescription: yes; Single use: no
On the market
Drill Bit 2.4 mm AO Shank 41839-29A
Brainlab SE
41839-29A04056481143237
Prescription: yes; Single use: no
On the market
Drill Bit 2.6 mm AO Shank 41839-69A
Brainlab SE
41839-69A04056481143176
Prescription: yes; Single use: no
On the market
Drill Bit 2.6 mm AO Shank Depth Control 41839-65A
Brainlab SE
41839-65A04056481143114
Prescription: yes; Single use: no
On the market
Drill Bit 3.2 mm Depth Control (200 mm) 41839-37A
Brainlab SE
41839-37A04056481143206
Prescription: yes; Single use: no
On the market
Drill Bit 4.5 mm AO Shank 41839-45A
Brainlab SE
41839-45A04056481143190
Prescription: yes; Single use: no
On the market
Drill Guide Array 51839-03
Brainlab SE
51839-0304056481144753
Prescription: yes; Single use: no
On the market
Drill Guide Depth Control (0 - 60 mm) 51839-01
Brainlab SE
51839-0104056481144777
Prescription: yes; Single use: no
On the market
Drill Guide Depth Control (60 - 100 mm) 51839-02
Brainlab SE
51839-0204056481144760
Prescription: yes; Single use: no
On the market
Drill Guide Handle Compact 51839-04
Brainlab SE
51839-0404056481146306
Prescription: yes; Single use: no
On the market
Drill Guide Trocar Insert (2.0 mm) 51839-93
Brainlab SE
51839-9304056481145057
Prescription: yes; Single use: no
On the market
Drill Guide Trocar Insert (2.4 mm) 51839-94
Brainlab SE
51839-9404056481145064
Prescription: yes; Single use: no
On the market
Drill Guide Trocar Insert (3.2 mm) 51839-96
Brainlab SE
51839-9604056481145088
Prescription: yes; Single use: no
On the market
Drill Guide Trocar Insert (4.5 mm) 51839-97
Brainlab SE
51839-9704056481145095
Prescription: yes; Single use: no
On the market
Drill Guide Tube (2.0 mm) 51839-20
Brainlab SE
51839-2004056481144821
Prescription: yes; Single use: no
On the market
Drill Guide Tube (3.2 mm) 51839-32
Brainlab SE
51839-3204056481144791
Prescription: yes; Single use: no
On the market
Drill Guide Tube (4.5 mm) 51839-45
Brainlab SE
51839-4504056481144784
Prescription: yes; Single use: no
On the market
Guide Tube Pedicle Access Needle (1.8 mm) 55844A
Brainlab SE
55844A / 55844A04056481001049
Prescription: yes; Single use: no
On the market
INSTRUMENT TRACKING ARRAY SPINE & TRAUMA (SIZE L) 55830-29
Brainlab SE
55830-29 / 55830-2904056481001230
Prescription: yes; Single use: no
On the market
INSTRUMENT TRACKING ARRAY SPINE & TRAUMA (SIZE ML) 55830-25A
Brainlab SE
55830-25A / 55830-25A04056481001254
Prescription: yes; Single use: no
On the market
PATIENT REFERENCE ARRAY SPINE & TRAUMA 55761B
Brainlab SE
55761B04056481146238
Prescription: yes; Single use: no
On the market
Patient Reference Attachment Arm for Skull Clamp 52001F
Brainlab SE
52001F / 52001F04056481002503
Prescription: yes; Single use: no
On the market
Patient Reference Attachment for Skull Clamp 41734
Brainlab SE
41734 / 4173404056481006297
Prescription: yes; Single use: no
On the market
PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S 55824
Brainlab SE
5582404056481145439
Length 139.7 mm; Width 31.6 mm; Height 45.2 mm
Prescription: yes; Single use: no
On the market
PROBE STRAIGHT (3.5 MM) FOR OPEN SURGERY 55830-43
Brainlab SE
55830-43 / 55830-4304056481001193
Prescription: yes; Single use: no
On the market
PROBE STRAIGHT (4.5 MM) FOR OPEN SURGERY 55830-40
Brainlab SE
55830-40 / 55830-4004056481001209
Prescription: yes; Single use: no
On the market
Quip Instrument Adapter Clamp For Cylindrical Instruments 58215
Brainlab SE
5821504056481147747
Prescription: no; Single use: no
On the market
Quip Instrument Adapter Clamp For Rectangular Instruments 58214
Brainlab SE
5821404056481147730
Prescription: no; Single use: no
On the market
Quip Instrument Adapter Clamp Softgrip Size M 58211
Brainlab SE
5821104056481147709
Prescription: no; Single use: no
On the market
Quip Instrument Adapter Clamp Softgrip Size XL 58213
Brainlab SE
5821304056481147723
Prescription: no; Single use: no
On the market
Quip Link Instrument Tracking Array For 3 Marker Spheres L 58195
Brainlab SE
5819504056481147662
Prescription: no; Single use: no
On the market
Quip Link Instrument Tracking Array For 3 Marker Spheres L1 58196
Brainlab SE
5819604056481147679
Prescription: no; Single use: no
On the market
Quip Link Instrument Tracking Array For 3 Marker Spheres ML 58194
Brainlab SE
5819404056481147655
Prescription: no; Single use: no
On the market
Spine Reference Adapter, Long 55761-02A
Brainlab SE
55761-02A04056481142742
Prescription: yes; Single use: no
On the market
Sterilization Tray Accessories Spine & Trauma 52326A
Brainlab SE
52326A04056481148218
Prescription: yes; Single use: no
On the market
Sterilization Tray Accessories Spine 52306C
Brainlab SE
52306C04056481148201
Prescription: yes; Single use: no
On the market

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