510(k) K241883
- Device
- DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Dispos
- Applicant
- Pro Med Instruments GmbH
- 510(k) number
- K241883
- Product code
- HBL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-26
- Date received
- 2024-06-28
- Regulation
- 882.4460
- Classification name
- Holder, Head, Neurosurgical (Skull Clamp)
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Anja Krumm
- Address
- Boetzinger Strasse 86 Freiburg DE 79111 79111
FDA Registration Numbers#
- 3010594904
- 3013111980
- 9680242
- 1531062
- 2029275
- 3003418325
- 3028006458
- 3007515069
- 1923569
- 3030733800
- 3009882462
- 2032092
- 3004929307
- 3003768277
- 3010326005
- 3002250546
- 1054811
- 3009217531
- 3009077524
- 1721676
- 8043933
- 3003923584
- 3003923579
- 3011547624
- 3018094310
- 1722447
- 3002808157
- 3027815
- 3013557562
- 3004608878
- 2182207
- 3011689956
Source Documents#
Other 510(k) Records For Product Code HBL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250423 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | 2025-11-06 |
| K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) | Pro Med Instruments GmbH | 2024-04-24 |
| K203505 | DORO QR3 Headrest System (Aluminum) | Pro Med Instruments GmbH | 2021-03-29 |
| K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) | Pro Med Instruments GmbH | 2020-06-02 |
| K191740 | DORO LUCENT® iXI and iMRI Headrest System | Pro Med Instruments GmbH | 2020-02-21 |
| K191701 | Arcus Head Fixation Frame | Mri Interventions, Inc. | 2019-11-15 |
| K191979 | DORO QR3 XTom Headholder System | Pro Med Instruments GmbH | 2019-10-22 |
| K163322 | TZ SKULL PIN Adult | Tz Medical, Inc. | 2017-02-23 |
| K142238 | MAYFIELD Skull Clamp | Integra LifeSciences Corporation | 2014-11-24 |
| K141950 | HFD100 ROCKER ARM ACCESSORY | Imris, Inc. | 2014-09-04 |
| K122225 | STERILE RADIOLUCENT SKULL PINS | Brainlab AG | 2013-04-26 |
| K130389 | MAYFIELD INFINITY XR2 SKULL CLAMP | Integra LifeSciences Corporation | 2013-04-23 |
| K120633 | MAYFIELD SKULL CLAMP | Integra LifeSciences Corporation | 2012-05-24 |
| K113748 | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) | Imris, Inc. | 2012-03-23 |
| K103493 | HEAD FIATION DEVICE (HFD 100) | Imris, Inc. | 2011-03-11 |